临床试验/NCT01094184

NCT01094184已完成4 期

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

Hoffmann-La Roche0 个研究点目标入组 49 人开始时间: 2010年3月最近更新: 2018年3月22日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 49
主要终点: Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

Bevacizumab 10 mg/kg Q2W

Experimental

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.

干预措施: Bevacizumab (Drug)

Bevacizumab 10 mg/kg Q2W

Experimental

干预措施: Paclitaxel (Drug)

Bevacizumab 10 mg/kg Q2W

Experimental

干预措施: Docetaxel (Drug)

Bevacizumab 15 mg/kg Q3W

Experimental

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.

干预措施: Bevacizumab (Drug)

Bevacizumab 15 mg/kg Q3W

Experimental

干预措施: Paclitaxel (Drug)

Bevacizumab 15 mg/kg Q3W

Experimental

干预措施: Docetaxel (Drug)

结局指标

主要结局

Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2

时间窗: 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.

Change From Baseline in FACT-B Score at Cycle 6

时间窗: 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.

Change From Baseline in FACT-B Score at Cycle 11

时间窗: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 13

时间窗: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 4

时间窗: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 17

时间窗: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 3

时间窗: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 5

时间窗: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 7

时间窗: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 8

时间窗: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score At Cycle 9

时间窗: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 10

时间窗: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 12

时间窗: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 14

时间窗: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 15

时间窗: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 16

时间窗: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 18

时间窗: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 20

时间窗: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 21

时间窗: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 22

时间窗: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 23

时间窗: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 24

时间窗: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 25

时间窗: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 26

时间窗: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 27

时间窗: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 28

时间窗: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 29

时间窗: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 30

时间窗: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 32

时间窗: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 36

时间窗: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 37

时间窗: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 42

时间窗: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 39

时间窗: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 44

时间窗: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at Cycle 46

时间窗: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

Change From Baseline in FACT-B Score at End of Study

时间窗: 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

时间窗: 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.

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3

时间窗: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4

时间窗: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5

时间窗: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6

时间窗: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7

时间窗: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8

时间窗: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9

时间窗: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10

时间窗: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11

时间窗: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14

时间窗: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15

时间窗: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17

时间窗: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12

时间窗: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13

时间窗: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16

时间窗: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26

时间窗: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18

时间窗: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20

时间窗: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21

时间窗: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22

时间窗: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23

时间窗: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24

时间窗: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25

时间窗: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27

时间窗: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28

时间窗: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29

时间窗: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30

时间窗: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2

时间窗: 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.

Change From Baseline in EQ-5D-VAS Score at Cycle 3

时间窗: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32

时间窗: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36

时间窗: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37

时间窗: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39

时间窗: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40

时间窗: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42

时间窗: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44

时间窗: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46

时间窗: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 4

时间窗: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 5

时间窗: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study

时间窗: 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-VAS Score at Cycle 6

时间窗: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 7

时间窗: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 10

时间窗: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 8

时间窗: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 17

时间窗: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 9

时间窗: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 11

时间窗: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 12

时间窗: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 13

时间窗: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 14

时间窗: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 15

时间窗: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 16

时间窗: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 20

时间窗: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 22

时间窗: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 18

时间窗: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 23

时间窗: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 24

时间窗: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 27

时间窗: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 21

时间窗: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 25

时间窗: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 26

时间窗: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 28

时间窗: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 30

时间窗: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 39

时间窗: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 29

时间窗: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 44

时间窗: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 32

时间窗: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 36

时间窗: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 37

时间窗: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 40

时间窗: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 42

时间窗: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at Cycle 46

时间窗: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

Change From Baseline in EQ-5D-VAS Score at End of Study

时间窗: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

次要结局

Percentage of Participants Who Died Due to Any Cause(Baseline up to death (overall approximately 5 years and 9 months))
Overall Survival(Baseline up to death (overall approximately 5 years and 9 months))
Percentage of Participants With Disease Progression(Baseline up to disease progression (overall approximately 5 years and 9 months))
Time to Disease Progression(Baseline up to disease progression (overall approximately 5 years and 9 months))
Percentage of Participants By Karnofsky Performance Status Scale Scores(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))

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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