Randomized CT to Evaluate Efficacy of Neoadjuvant Chemotherapy Customized by Levels of BRCA1-HER2 Negative Breast Cancer

• Status: Completed
• Trial end date: 2016-10-10
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Paclitaxel

Criteria

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.