Clinical trial · Interventional
Randomized CT to Evaluate Efficacy of Neoadjuvant Chemotherapy Customized by Levels of BRCA1-HER2 Negative Breast Cancer
Randomized Open-label, Multicentric, Phase II Clinical Trial to Evaluate the Efficacy of a Neoadjuvant Chemotherapy Scheme Customized by Levels of BRCA1 in Women With Primary HER2 Negative Breast Cancer (The BERNAQ Clinical Trial)
- 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)
Neoadjuvant chemotherapy (NAC) is increasingly used for early-stage operable breast cancer. Response of breast cancer to NAC is correlated with survival: patients who obtain greatest survival advantage are those who attain complete response of their primary tumor. BReast Cancer 1 (BRCA1) plays a crucial role in DNA repair and associations between BRCA1 mRNA expression and sensitivity to platinum and/or resistance to taxanes has been previously documented. We propose a two-arm, randomized, multi-centre, open-label phase II study to compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard FEC chemotherapy, being pathological complete response the primary endpoint.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel + Ciclofosfamide | Drug | — | UNRESOLVED |
| Epirubicin + Ciclofosfamide + Fluorouracil + Paclitaxel | Drug | — | UNRESOLVED |
| Epirubicin + Cisplatin + Fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard FEC Regimen
- description
- Epirubicin + Ciclofosfamide + Fluorouracil + Paclitaxel
- interventionNames
- Drug: Epirubicin + Ciclofosfamide + Fluorouracil + Paclitaxel
- type
- EXPERIMENTAL
- label
- No or Low BRCA1 expression
- description
- Epirubicin + Cisplatin + Fluorouracil
- interventionNames
- Drug: Epirubicin + Cisplatin + Fluorouracil
- type
- EXPERIMENTAL
- label
- Normal or High BRCA1 expression
- description
- Docetaxel + Ciclofosfamide
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female gender * 18 years or older * Performance Status- ECOG: 0-1 * Histologically confirmed invasive breast cancer * Primary tumor greater than 2 cm diameter * Any N (0-3) * No evidence of metastasis (M0), HER-2/ERBb2 negative. * Known hormone receptors status. * Haematopoietic status: Absolute neutrophil count \> 1.5 x 109/L; Platelet count \> 100 x 109/L * Hemoglobin at least 9 g/dl) * Hepatic status: Serum total bilirubin \< 1.5 x upper limit of normal (ULN), in the case of known Gilbert's syndrome, a higher serum total bilirubin (\< 2 x ULN) is allowed;AST and ALT \< 2.5 times ULN; Alkaline phosphatase \< 2.5 times ULN) * Renal status: Creatinine \< 1.5 mg/dl or Cl CR \> 60 ml/m * For women of childbearing potential Negative serum pregnancy test, within 2-weeks (preferably 7 days) prior to randomization. * Signed informed consent form (ICF). Exclusion Criteria: * Received any prior treatment for primary invasive breast cancer. * Previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated: * Basal and squamous cell carcinoma of the skin;Carcinoma in situ of the cervix. * Diagnosis of inflammatory breast cancer. * Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction uncontrolled hypertension (? 180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic therapy with oxygen. * Left Ventricular Ejection Fraction of \< 50% measured by echocardiography. * Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject?s safety. * Unresolved or unstable, serious adverse events from prior administration of another investigational drug. * Active or uncontrolled infection. * Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF. * Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies). * Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial. * Known immediate or delayed hypersensitivity reaction, idiosyncrasy or contraindication to drugs chemically related to any of the study treatments or their excipients. * Pregnant or lactating women. * Refusal to use contraception throughout the study (surgical sterilization, barrier methods associated with spermicidal gels or total abstinence). Use of hormonal contraceptives is not allowed. * Patient unable to comply with study procedures.
References
Publications (0)
Data not yet available