A Multicenter, Phase II, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Genentech, Inc.
- Enrollment
- 46
- Primary Endpoint
- Best Response
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
Brief Summary
This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent Form
- •Histologically or cytologically confirmed adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease
- •Age ≥ 18 years
- •Adequate left ventricular function at study entry, defined as an Left Ventricular Ejection Fraction (LVEF) \> 50% by either Multi Gated Acquisition(MUGA) scan or Electrocardiogram (ECHO)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Ability and willingness to comply with study and follow-up procedures
Exclusion Criteria
- •Unknown HER2 status or known HER2-positive status
- •Prior chemotherapy for locally recurrent or metastatic disease
- •Prior hormonal therapy within 2 weeks prior to Day 1
- •Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to Day 1
- •Prior adjuvant or neoadjuvant non-taxane chemotherapy within 6 months prior to Day 1
- •For patients who have received recent radiotherapy, ongoing Grade ≥ 3 acute toxicity
- •Patients with brain metastasis on full dose anticoagulation therapy
- •Life expectancy of \< 12 weeks
- •Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study
- •Inadequate organ function within 28 days prior to Day 1
Arms & Interventions
1
Intervention: bevacizumab
1
Intervention: sunitinib
1
Intervention: paclitaxel
2
Intervention: bevacizumab
2
Intervention: paclitaxel
Outcomes
Primary Outcomes
Best Response
Time Frame: From randomization until disease progression/recurrence (by patient)
The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
Secondary Outcomes
- Serious Adverse Events (SAEs)(30 days following the last administration of study treatment)
- Grade ≥ 3 Adverse Events (AEs)(30 days following the last administration of study treatment)
- Adverse Events Leading to Death(30 days following the last administration of study treatment)
- Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction(30 days following the last administration of study treatment)
- Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption(30 days following the last administration of study treatment)