A Randomized Phase III 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab for the First-line Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Locally Recurrent or Metastatic Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Central European Cooperative Oncology Group
- Enrollment
- 564
- Locations
- 55
- Primary Endpoint
- Overall Survival (PP Population)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.
Detailed Description
Arm A: Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks Arm B: Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks In both arms treatment will be given until first disease progression (PD), unacceptable toxicity or withdrawal of patient consent. For patients who stop chemotherapy for any reason before PD (e.g. toxicity) the other treatment should be given as monotherapy until PD.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Survival (PP Population)
Time Frame: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.
Overall Survival (ITT Population)
Time Frame: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250.
Secondary Outcomes
- Observation Time (ITT Population)(Up to approximately 6 years)
- Best Overall Response (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Best Overall Response (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Unconfirmed Best Overall Response (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Unconfirmed Best Overall Response (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Objective Response Rate and Disease Control Rate (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Progression Free Survival (ITT Population)(Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.)
- Progression Free Survival (PP Population)(Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.)
- Time to Treatment Failure (ITT Population)(From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years)
- Objective Response Rate and Disease Control Rate (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Time to Treatment Failure (PP Population)(From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years)
- Time to Response (ITT Population)(Time from randomization until occurrence of response, assessed up 1.7 years)
- Unconfirmed Objective Response Rate and Disease Control Rate (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Time to Response (PP Population)(Time from randomization until occurrence of response, assessed up 1.7 years)
- Duration of Response (ITT Population)(Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.)
- Duration of Response (PP Population)(Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.)