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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.

研究概览

地位

完全的

条件

乳腺癌

干预/治疗

研究类型

介入性

注册 (实际的)

阶段

第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：非随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	药品：Bevacizumab Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion. 其他名称：阿瓦斯汀药品：Paclitaxel Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician. 药品：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.
实验性的：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.	药品：Bevacizumab Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion. 其他名称：阿瓦斯汀药品：Paclitaxel Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician. 药品：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.

参与者组/臂

干预/治疗

实验性的：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.

药品：Bevacizumab

Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.

其他名称：

阿瓦斯汀

药品：Paclitaxel

Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.

药品：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.

实验性的：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.

药品：Bevacizumab

Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.

其他名称：

阿瓦斯汀

药品：Paclitaxel

Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.

药品：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.

研究衡量的是什么？

主要结果指标

次要结果测量

结果测量	措施说明	大体时间
Percentage of Participants Who Died Due to Any Cause 大体时间：Baseline up to death (overall approximately 5 years and 9 months)		Baseline up to death (overall approximately 5 years and 9 months)
Overall Survival 大体时间：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 大体时间：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 大体时间：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 大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hoffmann-La Roche

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年3月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2010年3月16日

首先提交符合 QC 标准的

2010年3月25日

首次发布 (估计)

2010年3月26日

研究记录更新

最后更新发布 (实际的)

2018年3月22日

上次提交的符合 QC 标准的更新

2017年8月25日

最后验证

2017年8月1日

Bevacizumab的临床试验

Istituto Scientifico Romagnolo per lo Studio e...

完全的

转移性结直肠癌的序贯治疗策略 (ITACa)

转移性结直肠癌

意大利
West China Hospital

招聘中

Capeox 方案联合 Sintilimab 和 Bevacizumab 治疗胃癌

胃肿瘤

中国
Weill Medical College of Cornell University

终止

动脉内输注爱必妥和贝伐珠单抗治疗 22 岁以下患者的复发/难治性颅内神经胶质瘤

多形性胶质母细胞瘤 | 间变性星形细胞瘤 | 弥漫性脑桥脑胶质瘤 | 脑干胶质瘤 | 毛粘液样星形细胞瘤 | 脑干胶质瘤 | 脑纤维星形细胞瘤 | 混合性少突胶质细胞瘤-星形细胞瘤

美国
Northwell Health

完全的

超选择性动脉颅内输注阿瓦斯汀（贝伐珠单抗）

多形性胶质母细胞瘤 | 间变性星形细胞瘤

美国
Zhejiang Cancer Hospital

招聘中

序贯 AG 和 mFOLFOX 联合 Serplulimab 注射液和 Bevacizumab 注射液治疗未经治疗的晚期胰腺癌

不可切除的胰腺癌

中国
ARCAGY/ GINECO GROUP

主动，不招人

PEMBRO 与化疗在卵巢癌的 Neo Adj 治疗中。 (NEOPEMBROV)

卵巢癌第四期

法国
University of Nottingham

未知

角膜新生血管的管理策略

角膜新生血管
University Medical Center Groningen

完全的

肾细胞癌中的 VEGF 成像 (Renimage)

肾细胞癌

荷兰
Sixth Affiliated Hospital, Sun Yat-sen University

招聘中

mFOLFOX6+Bevacizumab+PD-1 单克隆抗体治疗局部晚期 MSS CRC (BASKETⅡ)

大肠癌 | 免疫疗法

中国
ARCAGY/ GINECO GROUP

主动，不招人

晚期上皮性卵巢癌复发患者的 Tri 协会 (BOLD)

上皮性卵巢癌 | 复发

法国

结果测量	措施说明	大体时间
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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)

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

Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

Bevacizumab的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Tanzania

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点