This phase II trial studies the side effects and how well carboplatin and paclitaxel given in combination with pertuzumab and trastuzumab or bevacizumab work in treating patients with breast cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pertuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Giving carboplatin and paclitaxel together with pertuzumab and trastuzumab or bevacizumab may kill more tumor cells.
Additional locations may be listed on ClinicalTrials.gov for NCT02436993.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. 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 human epidermal growth factor receptor 2 (HER2)-positive disease or with bevacizumab in HER2-negative disease. (Treatment study component)
II. To measure the microscopic complete pathological response (pCR) rates defined as post neoadjuvant therapy (yp)T0 or ypTis tumors in patients treated with this regimen in the neoadjuvant setting. (Treatment study component)
III. 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]). (Treatment study component)
IV. To determine the toxicity of this regimen. (Treatment study component)
V. To determine treatment adherence and delivered dose intensity of this regimen. (Treatment study component)
VI. To assess the correlation between pCR and cCR. (Treatment study component)
VII. To determine the rate of breast conservation following neoadjuvant therapy. (Treatment study component)
VIII. Determine treatment efficacy according to subgroups defined according to stage and receptor status. (Treatment study component)
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (HER2 POSITIVE): Patients receive paclitaxel intravenously (IV) over 1-3 hours and carboplatin IV over 60 minutes weekly for 12 weeks. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 weeks and pertuzumab IV over 30-60 minutes every 3 weeks for 4 doses.
ARM II (HER2 NEGATIVE): Patients receive paclitaxel and carboplatin as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes every other week for 5 doses.
After completion of study treatment, patients are followed up for 15 years.
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorRita S. Mehta