Abstract OT1-01-02: A phase II trial of neoadjuvant docetaxel/cyclophosphamide followed by epirubicin/cyclophosphamide for triple-negative breast cancer

BackgroundCurrently, an anthracycline followed by a taxane as adjuvant or neoadjuvant chemotherapy is considered the most effective treatment for patients with triple-negative breast cancer. However, docetaxel followed by an anthracycline as neoadjuvant chemotherapy results in a higher rate of pathological complete response (pCR) than the regimen including an anthracycline followed by docetaxel (Iwata et al. Jpn J Clin Oncol 2011). Adjuvant docetaxel/cyclophosphamide (DC) treatment resulted in prolonged survival compared to adjuvant doxorubicin/cyclophosphamide. Therefore, we planned a phase II trial of DC followed by epirubicin/cyclophosphamide (EC) (Trial registration: UMIN000011031).Trial designThis is a phase II trial to evaluate the efficacy and toxicity of DC followed by EC as neoadjuvant therapy for triple-negative breast cancer. Patients will receive four cycles of docetaxel (75 mg/m2) and cyclophosphamide (600 mg/m2) every 21 days, followed by four cycles of epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) every 21 days.Eligibility criteriaPatients with histologically diagnosed triple-negative breast cancer, T1–4, N1–3, or T2–T4, N0 based on a core needle biopsy, will be included in this trial. Eligible patients must be between 20 and 70 years of age with a performance status of 0–2 and adequate organ function. They must not have undergone any prior operation, radiation therapy, chemotherapy, endocrine therapy, or immunotherapy.Specific aimsThe primary ...

Source: Cancer Research - February 13, 2017 Category: Cancer & Oncology Authors: N Tanaka, A Hirano, H Inoue, K Ogura, A Hattori, N Jibiki, H Yukawa, A Matsuoka, A Kodera, M Kamimura, Y Naritaka, T Shimizu Tags: Ongoing Clinical Trials Source Type: research