A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)
25 августа 2017 г. обновлено: Hoffmann-La Roche
Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer
This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
49
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Bangor, Соединенное Королевство, LL57 2PD
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Cottingham, Соединенное Королевство, HU16 5JG
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Exeter, Соединенное Королевство, EX2 5DW
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Grimsby, Соединенное Королевство, DN33 2BA
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Harrogate, Соединенное Королевство, HG2 8AY
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Plymouth, Соединенное Королевство, PL6 8DH
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Portsmouth, Соединенное Королевство, PO6 3LY
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Preston, Соединенное Королевство, PR2 9HT
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Somerset, Соединенное Королевство, TA1 5DA
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Wolverhampton, Соединенное Королевство, WV10 0QP
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
Inclusion Criteria:
- Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease
- Participant who in the Investigator's opinion requires combination therapy for their disease
- Life expectancy of greater than or equal to (>/=)12 weeks
Exclusion Criteria:
- Previous chemotherapy for metastatic breast cancer
- Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
- Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Bevacizumab 10 mg/kg Q2W
Participants will receive bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
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Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Другие имена:
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician.
Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
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Экспериментальный: Bevacizumab 15 mg/kg Q3W
Participants will receive bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
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Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Другие имена:
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician.
Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Временное ограничение: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 3
Временное ограничение: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 4
Временное ограничение: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 5
Временное ограничение: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 6
Временное ограничение: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 7
Временное ограничение: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 8
Временное ограничение: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score At Cycle 9
Временное ограничение: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 10
Временное ограничение: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 11
Временное ограничение: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 12
Временное ограничение: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 13
Временное ограничение: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 14
Временное ограничение: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 15
Временное ограничение: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 16
Временное ограничение: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 17
Временное ограничение: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 18
Временное ограничение: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 20
Временное ограничение: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 21
Временное ограничение: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 22
Временное ограничение: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 23
Временное ограничение: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 24
Временное ограничение: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 25
Временное ограничение: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 26
Временное ограничение: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 27
Временное ограничение: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 28
Временное ограничение: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 29
Временное ограничение: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 30
Временное ограничение: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 32
Временное ограничение: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 36
Временное ограничение: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 37
Временное ограничение: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 39
Временное ограничение: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 42
Временное ограничение: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 44
Временное ограничение: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 46
Временное ограничение: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at End of Study
Временное ограничение: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
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Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
Временное ограничение: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
Временное ограничение: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
Временное ограничение: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
Временное ограничение: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
Временное ограничение: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
Временное ограничение: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
Временное ограничение: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
Временное ограничение: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
Временное ограничение: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
Временное ограничение: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
Временное ограничение: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
Временное ограничение: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
Временное ограничение: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
Временное ограничение: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
Временное ограничение: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
Временное ограничение: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
Временное ограничение: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
Временное ограничение: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
Временное ограничение: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
Временное ограничение: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
Временное ограничение: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
Временное ограничение: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
Временное ограничение: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
Временное ограничение: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
Временное ограничение: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
Временное ограничение: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
Временное ограничение: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
Временное ограничение: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
Временное ограничение: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
Временное ограничение: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
Временное ограничение: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
Временное ограничение: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
Временное ограничение: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
Временное ограничение: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
Временное ограничение: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
Временное ограничение: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
Временное ограничение: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
|
Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
Временное ограничение: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 3
Временное ограничение: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 4
Временное ограничение: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 5
Временное ограничение: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 6
Временное ограничение: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 7
Временное ограничение: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 8
Временное ограничение: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 9
Временное ограничение: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 10
Временное ограничение: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 11
Временное ограничение: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 12
Временное ограничение: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 13
Временное ограничение: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 14
Временное ограничение: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 15
Временное ограничение: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 16
Временное ограничение: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 17
Временное ограничение: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 18
Временное ограничение: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 20
Временное ограничение: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 21
Временное ограничение: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 22
Временное ограничение: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 23
Временное ограничение: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 24
Временное ограничение: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 25
Временное ограничение: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 26
Временное ограничение: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 27
Временное ограничение: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 28
Временное ограничение: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 29
Временное ограничение: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 30
Временное ограничение: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 32
Временное ограничение: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 36
Временное ограничение: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 37
Временное ограничение: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 39
Временное ограничение: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 40
Временное ограничение: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 42
Временное ограничение: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 44
Временное ограничение: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 46
Временное ограничение: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at End of Study
Временное ограничение: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants Who Died Due to Any Cause
Временное ограничение: Baseline up to death (overall approximately 5 years and 9 months)
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
|
Overall Survival
Временное ограничение: Baseline up to death (overall approximately 5 years and 9 months)
|
Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause.
Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place.
Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive.
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
Percentage of Participants With Disease Progression
Временное ограничение: Baseline up to disease progression (overall approximately 5 years and 9 months)
|
Disease progression was defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
|
Baseline up to disease progression (overall approximately 5 years and 9 months)
|
|
Time to Disease Progression
Временное ограничение: Baseline up to disease progression (overall approximately 5 years and 9 months)
|
Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place.
Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date.
Disease progression was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
|
Baseline up to disease progression (overall approximately 5 years and 9 months)
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Временное ограничение: Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment.
Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease).
Higher score means higher ability to perform daily tasks.
|
Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 марта 2010 г.
Первичное завершение (Действительный)
1 декабря 2015 г.
Завершение исследования (Действительный)
1 декабря 2015 г.
Даты регистрации исследования
Первый отправленный
16 марта 2010 г.
Впервые представлено, что соответствует критериям контроля качества
25 марта 2010 г.
Первый опубликованный (Оценивать)
26 марта 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
22 марта 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
25 августа 2017 г.
Последняя проверка
1 августа 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Кожные заболевания
- Новообразования
- Новообразования по локализации
- Заболевания груди
- Новообразования молочной железы
- Тройные негативные новообразования молочной железы
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Противоопухолевые агенты
- Модуляторы тубулина
- Антимитотические агенты
- Модуляторы митоза
- Противоопухолевые агенты растительного происхождения
- Противоопухолевые агенты, иммунологические
- Ингибиторы ангиогенеза
- Агенты, модулирующие ангиогенез
- Вещества роста
- Ингибиторы роста
- Доцетаксел
- Паклитаксел
- Бевацизумаб
Другие идентификационные номера исследования
- ML22780
- 2009-014279-37
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .