Phase 4
Completed N=49
A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer
Source: ClinicalTrials.gov NCT01094184 ↗Enrolled (actual)
49
Serious AEs
44.9%
Results posted
Mar 2018
Primary outcomePrimary: Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 — 98.3; 102.21; 5.83; -2.48 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 |
98.3; 102.21; 5.83; -2.48 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 3 |
14.56 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 4 |
1.29; 0.09 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 5 |
-10.77; 4.50 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 6 |
9.47; 10.08 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 7 |
-6.24; 1.83 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 8 |
15.01; 15.44 | — |
| PRIMARY Change From Baseline in FACT-B Score At Cycle 9 |
-2.43; 7.00 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 10 |
2.71; 4.61 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 11 |
6.67; 8.17 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 12 |
9.22; 21.89 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 13 |
-8.00 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 14 |
6.83; 2.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 15 |
-6.67 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 16 |
11.83 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 17 |
22.63 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 18 |
10.28; 5.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 20 |
20.06 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 21 |
25.75; 10.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 22 |
13.67 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 23 |
9.67; 7.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 24 |
6.00 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 25 |
11.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 26 |
3.22 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 27 |
-26.78; 12.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 28 |
16.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 29 |
-3.00; 9.78 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 30 |
-3.11 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 32 |
10.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 36 |
3.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 37 |
5.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 39 |
9.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 42 |
10.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 44 |
11.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at Cycle 46 |
13.33 | — |
| PRIMARY Change From Baseline in FACT-B Score at End of Study |
-10.33; -1.01 | — |
| PRIMARY Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 |
0.6391; 0.8152; 0.1090; -0.2074 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3 |
0.1920 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4 |
-0.0105; -0.0906 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5 |
-0.1164; 0.2280 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6 |
0.0474; -0.0735 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7 |
-0.0331 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8 |
0.0627; -0.0523 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9 |
-0.1904 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10 |
0.0253; -0.0540 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11 |
0.0018 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12 |
0.0997; -0.0520 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13 |
-0.0930 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14 |
0.0620; -0.3320 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15 |
0.0175 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16 |
0.0060 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17 |
0.1057 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18 |
0.0970; -0.1570 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20 |
0.1035 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21 |
0.2955; -0.1570 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22 |
0.0710 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23 |
0.0625; -0.2280 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24 |
0.0540 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25 |
-0.3320 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26 |
0.0180 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27 |
0.0540; -0.3320 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28 |
-0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29 |
-0.0860; -0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30 |
0.0540 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32 |
-0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36 |
-0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37 |
-0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39 |
-0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40 |
-0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42 |
-0.2610 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44 |
-0.3320 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46 |
-0.3320 | — |
| PRIMARY Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study |
-0.1344; -0.1178 | — |
| PRIMARY Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2 |
64.8; 60.3; -1.0; -8.3 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 3 |
20.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 4 |
-1.9; 3.3 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 5 |
-8.2; 7.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 6 |
9.8; 21.4 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 7 |
-3.6; -9.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 8 |
11.0; 35.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 9 |
-5.8; 27.5 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 10 |
6.0; 14.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 11 |
2.0; 40.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 12 |
13.7; 60.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 13 |
-3.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 14 |
-5.0; 9.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 15 |
5.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 16 |
7.3 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 17 |
30.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 18 |
9.5; 10.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 20 |
15.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 21 |
27.5; 8.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 22 |
52.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 23 |
23.5; 10.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 24 |
-20.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 25 |
9.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 26 |
-20.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 27 |
-20.0; 10.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 28 |
9.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 29 |
-20.0; 10.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 30 |
-20.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 32 |
9.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 36 |
8.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 37 |
8.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 39 |
8.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 40 |
5.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 42 |
7.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 44 |
13.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at Cycle 46 |
14.0 | — |
| PRIMARY Change From Baseline in EQ-5D-VAS Score at End of Study |
-2.7; -1.4 | — |
| SECONDARY Percentage of Participants Who Died Due to Any Cause |
97.1; 84.6 | — |
| SECONDARY Overall Survival |
11.6; 18.9 | — |
| SECONDARY Percentage of Participants With Disease Progression |
74.3; 69.2 | — |
| SECONDARY Time to Disease Progression |
6.7; 7.9 | — |
| SECONDARY Percentage of Participants By Karnofsky Performance Status Scale Scores |
3.0; 8.0; 9.0; 8.0; 27.0; 25.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01094184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.