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A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)

2017年8月25日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

49

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
      • Bangor、イギリス、LL57 2PD
      • Cottingham、イギリス、HU16 5JG
      • Exeter、イギリス、EX2 5DW
      • Grimsby、イギリス、DN33 2BA
      • Harrogate、イギリス、HG2 8AY
      • Plymouth、イギリス、PL6 8DH
      • Portsmouth、イギリス、PO6 3LY
      • Preston、イギリス、PR2 9HT
      • Somerset、イギリス、TA1 5DA
      • Wolverhampton、イギリス、WV10 0QP

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
他の名前：
  • アバスチン
薬：Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
薬：Docetaxel
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.
実験的：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.
薬：Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
他の名前：
  • アバスチン
薬：Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
薬：Docetaxel
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
時間枠：Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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.
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 3
時間枠：Baseline, Cycle 3 (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 3 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 4
時間枠：Baseline, Cycle 4 (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 4 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 5
時間枠：Baseline, Cycle 5 (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 5 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 6
時間枠：Baseline, Cycle 6 (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 6 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 7
時間枠：Baseline, Cycle 7 (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 7 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 8
時間枠：Baseline, Cycle 8 (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 8 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score At Cycle 9
時間枠：Baseline, Cycle 9 (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 9 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 10
時間枠：Baseline, Cycle 10 (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 10 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 11
時間枠：Baseline, Cycle 11 (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 11 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 12
時間枠：Baseline, Cycle 12 (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 12 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 13
時間枠：Baseline, Cycle 13 (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 13 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 14
時間枠：Baseline, Cycle 14 (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 14 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 15
時間枠：Baseline, Cycle 15 (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 15 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 16
時間枠：Baseline, Cycle 16 (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 16 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 17
時間枠：Baseline, Cycle 17 (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 17 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 18
時間枠：Baseline, Cycle 18 (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 18 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 20
時間枠：Baseline, Cycle 20 (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 20 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 21
時間枠：Baseline, Cycle 21 (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 21 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 22
時間枠：Baseline, Cycle 22 (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 22 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 23
時間枠：Baseline, Cycle 23 (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 23 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 24
時間枠：Baseline, Cycle 24 (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 24 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 25
時間枠：Baseline, Cycle 25 (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 25 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 26
時間枠：Baseline, Cycle 26 (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 26 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 27
時間枠：Baseline, Cycle 27 (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 27 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 28
時間枠：Baseline, Cycle 28 (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 28 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 29
時間枠：Baseline, Cycle 29 (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 29 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 30
時間枠：Baseline, Cycle 30 (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 30 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 32
時間枠：Baseline, Cycle 32 (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 32 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 36
時間枠：Baseline, Cycle 36 (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 36 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 37
時間枠：Baseline, Cycle 37 (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 37 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 39
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Who Died Due to Any Cause
時間枠：Baseline up to death (overall approximately 5 years and 9 months)
Baseline up to death (overall approximately 5 years and 9 months)
Overall Survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hoffmann-La Roche

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2010年3月1日

一次修了 (実際)

2015年12月1日

研究の完了 (実際)

2015年12月1日

試験登録日

最初に提出

2010年3月16日

QC基準を満たした最初の提出物

2010年3月25日

最初の投稿 (見積もり)

2010年3月26日

学習記録の更新

投稿された最後の更新 (実際)

2018年3月22日

QC基準を満たした最後の更新が送信されました

2017年8月25日

最終確認日

2017年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • ML22780
  • 2009-014279-37

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

乳がんの臨床試験

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