A Pilot, Phase II, Multicenter, Open-Label, Prospective Evaluation of Docetaxel and Bevacizumab ± Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Breast Cancer
- Sponsor
- Sanofi
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS) Rate: Percentage of Participants With PFS
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT).
All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.
Detailed Description
The study included: * Study registration on Day 1: Treatment Cycle 1 was initiated within 14 days of signing informed consent * Treatment was administered in 3 week treatment cycles until the participant developed unacceptable toxicity, had disease progression, withdrew consent, or died * If participants experienced a complete response (CR), partial response (PR), or stable disease (SD) at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel, they could continue on bevacizumab and/or trastuzumab until they developed unacceptable toxicity, had disease progression, or withdrew consent * Participants had follow-up assessments within 30 days after discontinuation of treatment with the last of the study drugs for any reason other than death
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Docetaxel and Bevacizumab
Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Intervention: Bevacizumab
Docetaxel and Bevacizumab
Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Intervention: Docetaxel
Docetaxel, Bevacizumab and Trastuzumab
Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Intervention: Bevacizumab
Docetaxel, Bevacizumab and Trastuzumab
Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Intervention: Docetaxel
Docetaxel, Bevacizumab and Trastuzumab
Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Intervention: Trastuzumab
Outcomes
Primary Outcomes
Progression-free Survival (PFS) Rate: Percentage of Participants With PFS
Time Frame: Up to 6 months and 12 months after treatment initiation
PFS was the time from registration to first documentation of * progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance * symptomatic deterioration * death due to any cause (in absence of PD). The Percentage of participants with PFS is reported. For the analysis, participants were censored * on the last available tumor assessment date on study treatment if they * had no PFS event * were on anticancer therapy not related to study treatment * on the registration date if they * did not receive study drug * had no post baseline tumor assessment
Time to Progression-free Survival (PFS)
Time Frame: From treatment initiation to PFS event (up to June 2011)
Time to PFS was the interval from the date of registration to the earliest of the following documented dates: * PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance) * symptomatic deterioration * death. Time to PFS was estimated from Kaplan-Meier Plots.
Secondary Outcomes
- Confirmed Overall Response (OR) Based on RECIST Criteria(From treatment initiation to June 2011)
- Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria(From treatment initiation to June 2011)
- Duration of Response (DR)(From treatment initiation to June 2011)
- Overall Survival (OS) Time(From treatment initiation to June 2011)
- Number of Participants With Adverse Events (AE)(From treatment initiation to 30 days after the last dose of study treatment)