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Mirvetuximab Soravtansine for Breast Cancer (IMGN853 Trial)

Phase 1
Waitlist Available
Led By Kimberly Blackwell, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 9 weeks
Awards & highlights
No Placebo-Only Group

Summary

The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects the amount and activity of folate receptor alpha proteins in tumor cells of patients who have completed standard neoadjuvant treatment and are scheduled to have their tumors surgically removed.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in breast tumor FRα expression before and after treatment with mirvetuximab soravtansine
Secondary study objectives
Breast
Change in tumor cell death markers
Change in tumor cell proliferation, as measured by Ki67 expression
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mirvetuximab SoravtansineExperimental Treatment1 Intervention
Participants will receive 2 doses of Mirvetuximab Soravtansine after neoadjuvant chemotherapy and before surgical resection of tumor.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,457 Previous Clinical Trials
2,971,323 Total Patients Enrolled
55 Trials studying Breast Cancer
9,445 Patients Enrolled for Breast Cancer
National Comprehensive Cancer NetworkNETWORK
120 Previous Clinical Trials
8,022 Total Patients Enrolled
3 Trials studying Breast Cancer
428 Patients Enrolled for Breast Cancer
Kimberly Blackwell, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
89 Total Patients Enrolled
2 Trials studying Breast Cancer
57 Patients Enrolled for Breast Cancer
~0 spots leftby Dec 2025
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