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Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT03106077
Recruitment Status : Completed
First Posted : April 10, 2017
Results First Posted : November 19, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anatomic 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
Intervention Biological: Mirvetuximab Soravtansine
Enrollment 96
Recruitment Details  
Pre-assignment Details 96 participants signed consent, 54 enrolled during prescreening and 42 enrolled during enrollment, 94 were ineligible due to 4 died prior to starting treatment, 1 found not to be Triple negative breast cancer, 4 withdrew, 73 FR alpha negative, 11 insufficient tissue for analysis of FR alpha and 1 trial closed prior to enrollment.
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) Cohort B: Localized Breast Cancer
Hide Arm/Group Description 6 mg/kg IMGN853 IV Q3W 6 mg/kg IMGN853 IV Q3W for 4 cycles
Period Title: Overall Study
Started 96 0
Completed 2 0
Not Completed 94 0
Reason Not Completed
Screen Failure             94             0
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer(TNBC)
Hide Arm/Group Description 6 mg/kg IMGN853 IV Q3W
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
data provided for 2 participants completed the study for Cohort A; no participants moved to Cohort B
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
40
(39 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Metastatic Participants With Radiographic Response
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
We did not enroll enough patients to determine if 20% of patients with metastatic FR+ had a response to mirvetuximab soravtansine.
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Hide Arm/Group Description:
6 mg/kg IMGN853 IV Q3W
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Number of Neoadjuvant Participants With Pathologic Response
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
We did not enroll patients in this cohort and no data was collected for this cohort.
Arm/Group Title Cohort B: Localized Breast Cancer
Hide Arm/Group Description:
6 mg/kg IMGN853 IV Q3W for 4 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Radiographic Response Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Hide Arm/Group Description:
6 mg/kg IMGN853 IV Q3W
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
4.Secondary Outcome
Title Number of Participants With Stable Disease
Hide Description [Not Specified]
Time Frame From the baseline to the study until disease progression or death from any cause, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Hide Arm/Group Description:
6 mg/kg IMGN853 IV Q3W
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
5.Secondary Outcome
Title Number of Participants With Progressive Disease
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Hide Arm/Group Description:
6 mg/kg IMGN853 IV Q3W
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
6.Secondary Outcome
Title Number of Metastatic Participants With Duration of Response
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Hide Arm/Group Description:
6 mg/kg IMGN853 IV Q3W
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
7.Secondary Outcome
Title Compare Participants Disease Response FRalpha+ Chemotherapy Resistant Disease vs Similar Molecular Features Who Receive Standard Taxane-based Chemotherapy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
We did not enroll patients in cohort A and no data was collected for this cohort.
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Hide Arm/Group Description:
6 mg/kg IMGN853 IV Q3W
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events collected from the initiation of study drugs up to last dose of study drugs, up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Hide Arm/Group Description 6 mg/kg IMGN853 IV Q3W
All-Cause Mortality
Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Affected / at Risk (%)
Total   0/2 (0.00%)    
Hide Serious Adverse Events
Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  1/2 (50.00%)  1
Eye disorders   
Grade 1 Blurred Vision  1  1/2 (50.00%)  1
Grade 2 Blurred Vision  2  1/2 (50.00%)  1
Keratopathy  2  1/2 (50.00%)  1
Hepatobiliary disorders   
Elevated liver enzymes  2  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Neutropathy  2  1/2 (50.00%)  1
Myalgia  2  1/2 (50.00%)  1
Nervous system disorders   
Peripheral  2  1/2 (50.00%)  1
1
Term from vocabulary, CTCAE (4.0)
2
Term from vocabulary, CTCAE (4.03)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stacy Moulder, Professor, Breast Medical Oncology
Organization: UT MD Anderson Cancer Center
Phone: (713) 792-2817
EMail: smoulder@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03106077    
Other Study ID Numbers: 2016-0683
NCI-2018-01213 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0683 ( Other Identifier: M D Anderson Cancer Center )
First Submitted: April 4, 2017
First Posted: April 10, 2017
Results First Submitted: October 1, 2020
Results First Posted: November 19, 2020
Last Update Posted: December 2, 2020