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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Given IV
M D Anderson Cancer Center
Houston, Texas, United States
Number of Metastatic Participants With Radiographic Response
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). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From the registration to the study until disease progression or death from any cause, whichever occurred first, assessed up to 2 years
Number of Neoadjuvant Participants With Pathologic Response
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.
Time frame: From baseline to the study until disease progression or surgery, assessed up to 6 months
Number of Participants With Radiographic Response Rate
Tumor response for patients with measurable lesions should be assessed using RECIST 1.1 (Eisenhauer 2009, 0). Patients with measurable lesions should be assessed using CT or MRI scan approximately every second cycle, from the date of first dose until the 30-day Follow-up visit. Although progression may be determined by the investigator based upon clinical deterioration, every effort should be made to document progression using radiographic methods. The basis for determination of progression per clinical deterioration should be documented.
Time frame: From the baseline to the study until disease progression or death from any cause, whichever occurred first
Number of Participants With Stable Disease
Time frame: From the baseline to the study until disease progression or death from any cause, whichever occurred first
Number of Participants With Progressive Disease
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From the baseline to the study until disease progression or death from any cause, whichever occurred first
Number of Metastatic Participants With Duration of Response
Determine duration of response metastatic TNBC patients treated with mirvetuximab soravtansine .
Time frame: From the date of enrollment/baseline of the study until disease progression or death from any cause, whichever occurred first, up to 2 years
Compare Participants Disease Response FRalpha+ Chemotherapy Resistant Disease vs Similar Molecular Features Who Receive Standard Taxane-based Chemotherapy
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
Time frame: From the date of enrollment/baseline of the study until disease progression or death from any cause, whichever occurred first
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