Phase 2
Completed N=96
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
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
Source: ClinicalTrials.gov NCT03106077 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Number of Metastatic Participants With Radiographic Response — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Metastatic Participants With Radiographic Response |
— | — |
| PRIMARY Number of Neoadjuvant Participants With Pathologic Response |
— | — |
| SECONDARY Number of Participants With Radiographic Response Rate |
2 | — |
| SECONDARY Number of Participants With Stable Disease |
1 | — |
| SECONDARY Number of Participants With Progressive Disease |
1 | — |
| SECONDARY Number of Metastatic Participants With Duration of Response |
2 | — |
| SECONDARY Compare Participants Disease Response FRalpha+ Chemotherapy Resistant Disease vs Similar Molecular Features Who Receive Standard Taxane-based Chemotherapy |
— | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Confirmed invasive triple-negative breast cancer defined as estrogen receptor (ER) = 25% of cells having >= 1+ expression
- (For Cohort A) Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). (For cohort B) Clinical or radiologic primary tumor size of at least 1.5 cm prior to enrollment onto protocol 2014-0185 (ARTEMIS). Primary tumor of at least 1.0 cm or evidence of continued lymph node involvement by imaging (ultrasound or magnetic resonance imaging [MRI]) after adriamycin-based neoadjuvant therapy
- (For cohort B): Primary tumor sample collected before NACT started (on ARTEMIS) and underwent molecular testing for integral biomarkers including immunohistochemical assessment of FRalpha
- (For cohort A): No limit on prior therapies for metastatic disease. (Relapse of disease within 6 months of adjuvant or neoadjuvant chemotherapy is considered 1 line of therapy for metastatic disease). (For cohort B): received at least one dose of an anthracycline-based NACT. Patients are eligible if therapy was discontinued due to disease progression or therapy intolerance. Patients with disease progression on anthracycline-based therapy should be evaluated by the surgical team. If the patient is deemed inoperable at the time of evaluation, the patient may continue to undergo protocol therapy with a goal of reduction in tumor size to become operable. If the patient is deemed at high risk of becoming inoperable by the surgical team based upon tumor size or location, the patient will be considered ineligible for study and will be recommended to go to surgery
- (For cohort B): Primary tumor size of at least 1.0 cm by imaging (ultrasound or MRI) or evidence of continued lymph node involvement by imaging (ultrasound or MRI) after adriamycin-based neoadjuvant therapy
- (For cohort B): Baseline multigated acquisition (MUGA) or echocardiogram showing left ventricular ejection fraction (LVEF) >= 50% within 6 weeks prior to initiation of NACT
- (For both cohorts A and B): Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- (For both cohorts A and B): Platelets >= 100 x 10^9/L
- (For both cohorts A and B): Hemoglobin (Hb) > 9 G/dL
- (For both cohorts A and B): Total serum bilirubin = 2
- Signed informed consent obtained prior to any screening procedures
- (For cohort A only): Time from prior therapy: a. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter. Hormonal therapy is not considered anti-neoplastic therapy. b. Radiotherapy: wide-field radiotherapy (e.g. > 30% of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
- (For cohort B only): Patients must have at least 3 and no more than 5 weeks between anthracycline-based therapy and start of treatment with mirvetuximab soravtansine
- (For both cohorts A and B): Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy to grade 1 or less (except alopecia)
- (For both cohorts A and B): Women of child-hearing potential (WCBP) must have a negative pregnancy test within 3 days prior to the first dose of study treatment
Exclusion Criteria
- Pregnant or lactating women
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
- (For Cohort B only): Presence of metastatic disease or prior radiation therapy of the primary breast carcinoma or axillary lymph nodes
- Women of child-bearing potential (WCBP), defined as all women capable of becoming pregnant, won't use highly effective methods of contraception during the study and 12 weeks after. Highly effective contraception methods include combination of any two of the following:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom or
Data sourced from ClinicalTrials.gov (NCT03106077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.