Clinical trial · Interventional
Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in BRCA-associated Triple-negative Locally Advanced Breast Cancer
Use of a Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in Patients With BRCA-associated Triple-negative Locally Advanced Breast Cancer
NCT07821229CI-TRIAL-00126323MCarb-Tactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This study was designed to evaluate the safety and efficacy of neoadjuvant therapy with mitomycin and carboplatin in patients with BRCA-associated locally advanced triple-negative breast cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA 1 Gene Mutation | — | UNRESOLVED | — |
| BRCA 2 Gene Mutation | — | UNRESOLVED | — |
| Breast Cancer (Early Breast Cancer) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Chemotherapy (NACT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MCarb - T (mitomycin + carboplatin, paclitaxel)
- description
- mitomycin at a dose of 10 mg/m2, carboplatin AUC5, paclitaxel 80 mg/m2
- interventionNames
- Procedure: Neoadjuvant Chemotherapy (NACT)
- type
- ACTIVE_COMPARATOR
- label
- AC - TCarb (doxorubicin + cyclophosphamide, paclitaxel + carboplatin)
- description
- doxorubicin at a dose of 60 mg/m2, cyclophosphamide 600 mg/m2, paclitaxel 80 mg/m2, carboplatin AUC2
- interventionNames
- Procedure: Neoadjuvant Chemotherapy (NACT)
Primary outcomes (1)
- measure
- Pathomorphological response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent to participate in the study; 2. Histopathological confirmation of triple-negative breast cancer; 3. Stage: clinical T1-T4, N0-3, M0; 4. Positive molecular genetic test for BRCA1\|2 gene mutation (PCR test or NGS result); 5. Age \> 18 years; 6. ECOG status 0-1. Exclusion Criteria: 1. Prior administration of any systemic therapy for breast cancer; 2. Stage IV disease; 3. Severe uncontrolled chronic comorbidities or acute illnesses; 4. Renal dysfunction; 5. Age \> 70 years; 6. Presence of a second malignant tumor (except for previously cured malignancies); 7. Pregnancy or breastfeeding; 8. Negative molecular genetic test for BRCA1\|2 gene mutation
References
Publications (0)
Data not yet available
No reference posted for this study.