Abstract OT3-1-01: A two-cohort, phase II, cardiac safety study of pertuzumab, trastuzumab, and neoadjuvant anthracycline-based chemotherapy in patients with HER2-positive, locally advanced, inflammatory, or early breast cancer

This study will evaluate the cardiac safety of two anthracycline-based neoadjuvant regimens in combination with P+T. Following surgery, all pts will receive adjuvant P+T. Trial design: In this non-randomized, open-label, phase II study, two parallel cohorts of pts receive different P-based neoadjuvant treatment regimens. In Cohort A, pts receive four 2-weekly cycles of ddAC, followed by 12 doses of weekly Ptx, plus four 3-weekly (q3w) cycles of P+T from the start of Ptx. In Cohort B, pts receive four q3w cycles of 5-fluorouracil, epirubicin, and cyclophosphamide, followed by four q3w cycles of D, plus four q3w cycles of P+T from the start of D. Following surgery, both cohorts receive 13 cycles of P+T. Eligibility: Pts with HER2-positive, locally advanced, inflammatory, or early BC (size >2 cm or >5 mm and node-positive) are eligible if they have a baseline LVEF ≥55% and an ECOG performance status ≤1. Among the exclusion criteria are prior incisional biopsy or excision of the primary tumor, prior systemic or radiation therapy for cancer, and prior chemopreventive agents. Pts are also excluded if they have poorly controlled hypertension, angina requiring medication, a history of congestive heart failure, serious or uncontrolled cardiac arrhythmia requiring treatment, or myocardial infarction within 6 months prior to enrollment. Aims: The primary objective is cardiac safety during the neoadjuvant period, assessed by incidence of symptomatic LVSD and LVEF changes. Secondary o...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Ongoing Clinical Trials Source Type: research