Trial · NCT03106077
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
NCT03106077, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer. Trials, record NCT03106077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03106077
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
- NCT number
- NCT03106077
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- 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
- Interventions
- Mirvetuximab Soravtansine
- First posted
- 2017-04-10
- Last updated
- 2020-12-02
- Results first posted
- 2020-11-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Metastatic Participants With Radiographic Response | From the registration to the study until disease progression or death from any cause, whichever occurred first, assessed up to 2 years | 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. |
| Primary | Number of Neoadjuvant Participants With Pathologic Response | From baseline to the study until disease progression or surgery, assessed up to 6 months | 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 | Number of Participants With Radiographic Response Rate | From the baseline to the study until disease progression or death from any cause, whichever occurred first | 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. |
| Secondary | Number of Participants With Stable Disease | From the baseline to the study until disease progression or death from any cause, whichever occurred first | |
| Secondary | Number of Participants With Progressive Disease | From the baseline to the study until disease progression or death from any cause, whichever occurred first | 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. |
| Secondary | Number of Metastatic Participants With Duration of Response | From the date of enrollment/baseline of the study until disease progression or death from any cause, whichever occurred first, up to 2 years | Determine duration of response metastatic TNBC patients treated with mirvetuximab soravtansine . |
| Secondary | Compare Participants Disease Response FRalpha+ Chemotherapy Resistant Disease vs Similar Molecular Features Who Receive Standard Taxane-based Chemotherapy | From the date of enrollment/baseline of the study until disease progression or death from any cause, whichever occurred first | 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 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Metastatic Participants With Radiographic Response | From the registration to the study until disease progression or death from any cause, whichever occurred first, assessed up to 2 years | We did not enroll enough patients to determine if 20% of patients with metastatic FR+ had a response to mirvetuximab soravtansine. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neoadjuvant Participants With Pathologic Response | From baseline to the study until disease progression or surgery, assessed up to 6 months | We did not enroll patients in this cohort and no data was collected for this cohort. | ||
| SECONDARY | Number of Participants With Radiographic Response Rate | From the baseline to the study until disease progression or death from any cause, whichever occurred first | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Stable Disease | From the baseline to the study until disease progression or death from any cause, whichever occurred first | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Progressive Disease | From the baseline to the study until disease progression or death from any cause, whichever occurred first | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Metastatic Participants With Duration of Response | From the date of enrollment/baseline of the study until disease progression or death from any cause, whichever occurred first, up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare Participants Disease Response FRalpha+ Chemotherapy Resistant Disease vs Similar Molecular Features Who Receive Standard Taxane-based Chemotherapy | From the date of enrollment/baseline of the study until disease progression or death from any cause, whichever occurred first | We did not enroll patients in cohort A and no data was collected for this cohort. |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Metastatic Participants With Radiographic Response | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 0 | Participants | ||
| Number of Participants With Radiographic Response Rate | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 2 | Participants | ||
| Number of Participants With Stable Disease | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | Participants | ||
| Number of Participants With Progressive Disease | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | Participants | ||
| Number of Metastatic Participants With Duration of Response | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 96 | |
| Overall Study | STARTED | Cohort B: Localized Breast Cancer | 0 | |
| Overall Study | COMPLETED | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 2 | |
| Overall Study | COMPLETED | Cohort B: Localized Breast Cancer | 0 | |
| Overall Study | NOT COMPLETED | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 94 | |
| Overall Study | NOT COMPLETED | Cohort B: Localized Breast Cancer | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
| other | Grade 1 Blurred Vision | Eye disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
| other | Grade 2 Blurred Vision | Eye disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
| other | Keratopathy | Eye disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
| other | Peripheral | Nervous system disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
| other | Neutropathy | Musculoskeletal and connective tissue disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
| other | Elevated liver enzymes | Hepatobiliary disorders | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 0 | 2 |
| Total, other adverse events | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 2 | 2 |
| Total, serious adverse events | Cohort A: Advanced Triple-Negative Breast Cancer (TNBC) | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03106077
GET https://conductscience.org/api/trials/v1/NCT03106077/registered