CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Mirvetuximab Soravtansinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03106077
NCT03106077Phase 2Completed
CompareCT.gov

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

M.D. Anderson Cancer Center·interventional·Posted Apr 10, 2017·Updated Dec 2, 2020

In Brief

A Phase 2 clinical trial evaluating Mirvetuximab Soravtansine for Anatomic Stage II Breast Cancer AJCC v8 and 20 related conditions. Completed, enrolled 96 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Negative, Folate Receptor Alpha Positive, HER2/Neu Negative, Progesterone Receptor Negative, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 10, 2017
Enrollment StartJun 5, 2017
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.2 years ago

Interventions

Mirvetuximab Soravtansinebiological

Given IV