Clinical trial · Interventional
BRCA1-associated DNA Repair Dysfunction in Patients With Early Triple Negative Breast Cancer Treated With Neoadjuvant Platinum-based Chemotherapy
Identification of BRCA1-associated DNA Repair Dysfunction in Patients With Early Triple Negative Breast Cancer Treated With Neoadjuvant Platinum-based Chemotherapy
NCT01672671CI-TRIAL-00019681completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy in correlation with BRCA1-associated DNA repair dysfunction in patients with early triple negative breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Triple Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin, Paclitaxel, Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant platinum-based chemotherapy
- description
- Doxorubicin, Paclitaxel, Cisplatin
- interventionNames
- Drug: Doxorubicin, Paclitaxel, Cisplatin
Primary outcomes (1)
- measure
- The pathological complete response rate to neoadjuvant platinum-based chemotherapy
- timeFrame
- after 8 weeks of neoadjuvant chemotherapy
- description
- Pathologic treatment response will be assessed in correlation with BRCA1-associated DNA repair dysfunction signature.
Secondary outcomes (2)
- measure
- Disease-free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients, age ≥18 years≤75; 2. Histologically confirmed invasive ER-, PR-, and HER2-negative (triple- negative) adenocarcinoma of the breast; 3. Clinical stage T1-2, N0-1, M0. Exclusion Criteria: 1. Previous treatment for this breast cancer 2. History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease 3. Pregnancy or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.