Clinical trial · Observational
BRCA and NACT in TNBC Patients
Impact of BRCA Mutation Status on Outcome and Response to Neoadjuvant Chemotherapy (NACT) in Triple-negative Breast Cancer (TNBC) Patients.
NCT05750719CI-TRIAL-00064405Light-BrightcompletedClinicalTrials.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 goal of this observational study is to evaluate data from patients with triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy (NACT) in order to better define the impact of germline BRCA1/2 (gBRCA1/2) mutation status on outcomes in this patient population. The aims of the study are: * To evaluate the rate of pathologic complete response (pCR) in patients with locally advanced TNBC who performed NACT, in relation to the mutational status of gBRCA. * To evaluate Evaluate Event Free survival (EFS) and Overall Survival (OS) in this patients population.
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 |
|---|---|---|---|
| Triple-Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BRCA1/2 genetic testing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with early triple negative breast cancer who received neoadjuvant chemotherapy.
- interventionNames
- Genetic: BRCA1/2 genetic testing
Primary outcomes (1)
- measure
- pathologic complete response (pCR) rate
- timeFrame
- 1 month
- description
- pCR rate of TNBC patients receiving NACT according to germline BRCA mutational status.
Secondary outcomes (2)
- measure
- Event Free Survival (EFS)
- timeFrame
- 1 month
- description
- EFS of TNBC patients receiving NACT according to germline BRCA mutational status.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Age older than 18 years. * Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. * Tumor lesion in the breast with a palpable size of ≥ 2 cm and/or ≥ 1.5 cm by ultrasound or magnetic resonance imaging (MRI). In case of inflammatory carcinoma, the extent of inflammation can be used as measurable lesion. * American Joint Commission on Cancer stage II or III invasive breast cancer. * Known estrogen (ER)- and progesterone (PgR)-receptor negative tumors. * Known HER-2/neu negative tumors, defined as IHC 1+/2+ or SISH not amplified. * Patients suitable for neoadjuvant chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2 or Karnowsky performance status index at least 80%. * Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 1 month prior to registration. * Laboratory requirements: * Hematology: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, Hemoglobin ≥ 10 g/dL. * Hepatic function: Total bilirubin \< 1 x UNL, ASAT (SGOT) and ALAT (SGPT)≤ 2.5 x UNL, Alkaline phosphatase ≤ 5 UNL. Patients with ASAT and / or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL are not eligible for the study. * Renal function: Creatinine ≤ 2 mg/dL, \< 1,25 UNL (or the calculated creatinine clearance ≥ 60 mL/min). * Paraffin tumor tissue block made available. * Availability to provide the set up of the histological preparations for molecular analysis. * Negative pregnancy test (urine or serum). * Patients must be available and compliant for treatment and follow-up. Exclusion Criteria: * Patients candidate for adjuvant chemotherapy. * Evidence of distant metastasis. * Prior chemotherapy for any malignancy. * Prior radiation therapy for breast cancer. * Pregnant or lactating patients. * Inadequate general condition. * Previous malignant disease. * Known or suspected congestive heart failure (\>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension, rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease. * History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
References
Publications (1)
- RESULTPavese F, Capoluongo ED, Muratore M, Minucci A, Santonocito C, Fuso P, Concolino P, Di Stasio E, Carbognin L, Tiberi G, Garganese G, Corrado G, Di Leone A, Generali D, Fragomeni SM, D'Angelo T, Franceschini G, Masetti R, Fabi A, Mule A, Santoro A, Belli P, Tortora G, Scambia G, Paris I. BRCA Mutation Status in Triple-Negative Breast Cancer Patients Treated with Neoadjuvant Chemotherapy: A Pivotal Role for Treatment Decision-Making. Cancers (Basel). 2022 Sep 21;14(19):4571. doi: 10.3390/cancers14194571. PMID 36230495