Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
Women's Triple-Negative First-Line Study: A Phase II Trial of Mirvetuximab Soravtansine in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NACT), Including a Lead-In Cohort to Establish Activity in Patients With Metastatic TNBC
This phase II trial studies how well mirvetuximab soravtansine works as first line in treating patients with triple negative breast cancer. Drugs used in chemotherapy, such as mirvetuximab soravtansine, 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.
PRIMARY OBJECTIVES: - I. Determine if mirvetuximab soravtansine as a single agent is likely to induce response in at least 20% of patients with metastatic folate receptor (FR) alpha+ triple negative breast cancer (TNBC). - II. Determine if mirvetuximab soravtansine as a single agent in the neoadjuvant setting will improve rates of excellent pathologic response (pathologic complete response [pCR]/residual cancer burden [RCB]-0 or RCB-I) from 5% to 20% in patients with high risk, chemotherapy insensitive, FRalpha+ TNBC. SECONDARY OBJECTIVES: - I. Determine the radiographic response rate as measured by ultrasound and/ or magnetic resonance imaging (MRI) (partial response + complete clinical response) for mirvetuximab soravtansine in chemotherapy insensitive, FRalpha + localized TNBC or using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with FRalpha+ advanced TNBC. - II. Determine toxicity of 4 cycles of mirvetuximab soravtansine given in the neoadjuvant setting following anthracycline based therapy (Cohort B) and unrestricted cycles in patients receiving therapy in the advanced/metastatic setting (Cohort A). - III. Determine disease free survival (DFS) at 3 years for patients treated with mirvetuximab soravtansine given in the neoadjuvant setting; progression free survival (PFS), duration of response (DOR) and overall survival at 3 years (overall survival [OS] at 3 years) in patients receiving therapy for advanced/ metastatic TNBC. - IV. Compare disease response (as measured by pCR/RCB-I) in patients with FRalpha+ chemotherapy resistant disease treated on clinical trial with mirvetuximab soravtansine in the neoadjuvant setting to those with similar molecular features who receive standard taxane-based chemotherapy as the second phase of their NACT. ;
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