Исследование Алисертиба в комбинации с эндокринной терапией у пациенток с HR-положительным, HER2-негативным рецидивирующим или метастатическим раком молочной железы (ALISCA-Breast1)
Исследование фазы 2 Алисертиба в комбинации с эндокринной терапией у пациентов с HR+, HER2-негативным рецидивирующим или метастатическим раком молочной железы
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Puma Biotechnology, Inc. Clinical Operations Senior Director
- Номер телефона: 424-248-6500
- Электронная почта: ClinicalTrials@pumabiotechnology.com
Места учебы
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Alicante, Испания, 03010
- Рекрутинг
- Hospital General Universitario Dr. Balmis
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Barakaldo, Испания, 48903
- Рекрутинг
- Hospital Universitario de Cruces
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Barcelona, Испания, 08035
- Рекрутинг
- Hospital Universitario Vall d'Hebron
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Barcelona, Испания, 08036
- Рекрутинг
- Hospital Clínico de Barcelona
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Bilbao, Испания, 48013
- Рекрутинг
- Hospital Universitario de Basurto
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Cáceres, Испания, 10003
- Рекрутинг
- Hospital San Pedro de Alcántara
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Granada, Испания, 18012
- Рекрутинг
- Hospital San Cecilio
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Huelva, Испания, 21005
- Рекрутинг
- Hospital Universitario Juan Ramon Jimenez
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Jaén, Испания, 23007
- Рекрутинг
- Hospital Universitario de Jaén
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Lleida, Испания, 25198
- Рекрутинг
- Hospital Universitario Arnau de Vilanova
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Madrid, Испания, 28040
- Рекрутинг
- Hospital Universitario Fundación Jiménez Díaz
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Seville, Испания, 41013
- Рекрутинг
- Hospital Universitario Virgen del Rocío
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Valencia, Испания, 46010
- Рекрутинг
- Hospital Clínico Universitario de Valencia
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Valencia, Испания, 46009
- Рекрутинг
- Fundación Instituto Valenciano de Oncología (IVO)
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Lisbon, Португалия, 1998-018
- Рекрутинг
- Hospital CUF Descobertas
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Lisbon, Португалия, 1099-023
- Рекрутинг
- Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
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Lisbon, Португалия, 1400-038
- Рекрутинг
- Fundação Champalimaud
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Porto, Португалия, 4200-072
- Рекрутинг
- Instituto Português Oncologia Do Porto
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 34235
- Рекрутинг
- Alabama Oncology
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85054
- Рекрутинг
- Mayo Clinic Hospital
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California
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Beverly Hills, California, Соединенные Штаты, 90211
- Рекрутинг
- Beverly Hills Cancer Center
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Fountain Valley, California, Соединенные Штаты, 92708
- Рекрутинг
- MemorialCare Orange Coast Medical Center
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Irvine, California, Соединенные Штаты, 92618
- Рекрутинг
- City of Hope at Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Соединенные Штаты, 90095
- Рекрутинг
- UCLA Department of Medicine - Hematology/Oncology
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Los Angeles, California, Соединенные Штаты, 90017
- Рекрутинг
- LA Cancer Network
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San Francisco, California, Соединенные Штаты, 94158
- Рекрутинг
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- Рекрутинг
- University of Colorado School of Medicine
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Connecticut
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New Haven, Connecticut, Соединенные Штаты, 06520
- Отозван
- Yale University, Yale Cancer Center
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Florida
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Jacksonville, Florida, Соединенные Штаты, 32256
- Рекрутинг
- Cancer Specialists of North Florida
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Jacksonville, Florida, Соединенные Штаты, 32224
- Рекрутинг
- Mayo Clinic Florida
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Tampa, Florida, Соединенные Штаты, 33612
- Рекрутинг
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30322
- Рекрутинг
- Winship Cancer Institute, Emory University
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- Рекрутинг
- University of Illinois Cancer Center
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Chicago, Illinois, Соединенные Штаты, 60637
- Рекрутинг
- The University of Chicago
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114
- Рекрутинг
- Massachusetts General Hospital
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Boston, Massachusetts, Соединенные Штаты, 02215
- Рекрутинг
- Dana-Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55455
- Рекрутинг
- University of Minnesota, Masonic Cancer Center
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Rochester, Minnesota, Соединенные Штаты, 55905
- Рекрутинг
- Mayo Clinic
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Missouri
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Columbia, Missouri, Соединенные Штаты, 65201
- Рекрутинг
- Missouri Cancer Associates
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Kansas City, Missouri, Соединенные Штаты, 64111
- Рекрутинг
- Saint Luke's Cancer Institute
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Springfield, Missouri, Соединенные Штаты, 65807
- Рекрутинг
- Oncology Hematology Associates
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St Louis, Missouri, Соединенные Штаты, 63110
- Рекрутинг
- Washington University School of Medicine
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Nevada
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Reno, Nevada, Соединенные Штаты, 89511
- Рекрутинг
- Cancer Care Specialists
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New York
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Rochester, New York, Соединенные Штаты, 14642
- Рекрутинг
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27514
- Рекрутинг
- UNC Hospitals, University of North Carolina at Chapel Hill
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43212
- Рекрутинг
- The Ohio State University, Stefanie Spielman Comprehensive Breast Center
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Maumee, Ohio, Соединенные Штаты, 43537
- Рекрутинг
- Taylor Cancer Research Center
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Pennsylvania
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Horsham, Pennsylvania, Соединенные Штаты, 19044
- Рекрутинг
- Alliance Cancer Specialists
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Рекрутинг
- University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- Рекрутинг
- University of Pittsburgh (UPMC)
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37203
- Рекрутинг
- Tennessee Oncology, Greco-Hainsworth Center for Research
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Texas
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Dallas, Texas, Соединенные Штаты, 75246
- Рекрутинг
- Texas Oncology
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Virginia
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Richmond, Virginia, Соединенные Штаты, 23229
- Рекрутинг
- Virginia Cancer Institute
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged ≥18 years at signing of informed consent.
- Pathology-confirmed diagnosis of breast cancer with evidence of recurrent or metastatic disease not amenable to curative therapy.
- Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
- Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
- HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines.
Exclusion Criteria:
- Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload.
- Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Alisertib 50 mg
Alisertib with selected endocrine therapy |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Другие имена:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
|
Экспериментальный: Alisertib 40 mg
Alisertib with selected endocrine therapy |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Другие имена:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
|
Экспериментальный: Alisertib 30 mg
Alisertib with selected endocrine therapy Cohort closed to enrollment in Amendment 4 |
Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.
Другие имена:
Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Objective Response Rate (ORR) Within Dose Subgroup
Временное ограничение: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
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Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
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Duration of Response (DOR) Within Dose Subgroup
Временное ограничение: From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
Duration of response is measured from the time at which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. |
From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
|
Disease Control Rate (DCR) Within Dose Subgroup
Временное ограничение: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or Stable Disease (SD) lasting for at least 24 weeks from randomization. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Progression Free Survival (PFS) Within Dose Subgroup
Временное ограничение: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented. |
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
|
Overall Survival (OS) Within Dose Subgroup
Временное ограничение: From date of randomization to death, assessed up to 48 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. |
From date of randomization to death, assessed up to 48 months
|
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Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population
Временное ограничение: From date of first dose through last dose plus 28 days, assessed up to 48 months
|
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose. |
From date of first dose through last dose plus 28 days, assessed up to 48 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
Временное ограничение: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Duration of Response (DOR) Within Biomarker-Defined Subgroup
Временное ограничение: From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. |
From start date of response (after date of randomization) to first PD, assessed up to 48 months
|
|
Disease Control Rate (DCR) Within Biomarker-Defined Subgroup
Временное ограничение: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 24 weeks from randomization. |
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
|
|
Progression Free Survival (PFS) Within Biomarker-Defined Subgroup
Временное ограничение: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented. |
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
|
|
Overall Survival (OS) Within Biomarker-Defined Subgroup
Временное ограничение: From date of randomization to death, assessed up to 48 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. |
From date of randomization to death, assessed up to 48 months
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Chief Reg Affairs, PV, Medical Affairs and Law Officer, Puma Biotechnology, Inc.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PUMA-ALI-1201
- 2024-511497-79-00 (Ктис)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.
In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.
Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.
Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
Сроки обмена IPD
Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
Критерии совместного доступа к IPD
Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.
Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .