Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
OBJECTIVES The study component is to evaluate the treatment response and toxicity of the protocol. Objectives for treatment study component: 1.1 To estimate 2-year progression-free survival in patients with breast cancer with tumor more than 1 cm and/or with clinically detected lymph node treated wi...
OBJECTIVES The study component is to evaluate the treatment response and toxicity of the protocol. Objectives for treatment study component: 1.1 To estimate 2-year progression-free survival in patients with breast cancer with tumor more than 1 cm and/or with clinically detected lymph node treated with neoadjuvant weekly Carboplatin and Paclitaxel combined with Trastuzumab + Pertuzumab in HER2-positive disease or with Bevacizumab in HER2-negative disease. 1.2 To measure the microscopic complete pathological response (pCR) rates defined as ypT0 or ypTis tumors in patients treated with this regimen in the neoadjuvant setting. 1.3 To assess complete clinical response (cCR) rates after treatment by physical exam and imaging tests (ultrasonography, mammography, or magnetic resonance imaging) clinical objective response rate (by Response Evaluation Criteria In Solid Tumors (RECIST)) 1.4 To determine the toxicity of this regimen. 1.5 To determine treatment adherence and delivered dose intensity of this regimen. 1.6 To assess the correlation between pCR and cCR. 1.7 To determine the rate of breast conservation following neoadjuvant therapy. 1.8 Determine treatment efficacy according to subgroups defined according to stage and receptor status.
Tracking Information
- NCT #
- NCT02436993
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rita Mehta, MD University of California, Irvine