Phase 3
Completed N=284
A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00929240 ↗Enrolled (actual)
284
Serious AEs
20.3%
Results posted
Mar 2015
Primary outcomePrimary: Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013) — 88.3; 75.8 percentage of participants
Summary
This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013) |
88.3; 75.8 | — |
| PRIMARY Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013) |
4.3; 11.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013) |
76.6; 85.7 | 0.113 |
| SECONDARY Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013) |
97.9; 98.9 | 0.580 |
| SECONDARY Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013) |
56.4; 36.3 | — |
| SECONDARY Overall Survival (Maintenance Phase Data Cutoff October 4, 2013) |
23.7; 39.0 | <0.0003 sig |
| SECONDARY Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013) |
71.6; 90.4; 49.4; 69.0 | — |
| SECONDARY Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013) |
88.3; 74.7 | — |
| SECONDARY Time To Progression (Maintenance Phase Data Cutoff October 4, 2013) |
4.3; 11.9 | <0.0001 sig |
| SECONDARY Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013) |
-3.51; -4.46; 0.76; -3.21; 4.17; -5.40 | — |
| SECONDARY Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase) |
8.8 | — |
| SECONDARY Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase) |
56.9 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- HER2-negative metastatic breast cancer
- candidates for taxane-based chemotherapy;
- ECOG performance status of 0 or 1.
Exclusion Criteria
- previous chemotherapy for metastatic breast cancer;
- prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;
- prior radiotherapy for treatment of metastatic disease;
- chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).
Data sourced from ClinicalTrials.gov (NCT00929240). 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.