Abstract OT1-04-04: A phase 2 randomized, double-blind, placebo-controlled trial of endocrine therapy {+/-} radium-223 dichloride in HER2-negative, hormone receptor-positive breast cancer patients with bone metastases

This study evaluates efficacy and safety of radium-223 versus placebo (pbo), each + endocrine treatment (ET), in patients with HER2- estrogen receptor+ (ER+)bone-dominant MBC (NCT02258464). Patients receive (1:1) radium-223 50 kBq/kg IV or pbo q 4 wk (6 cycles) + ET + denosumab or bisphosphonates + best supportive care. Stratification is by geographic region (EU/N America vs Asia), number of prior ET lines (1 vs ≥ 2) for MBC, and number of prior skeletal-related events (SREs) (1 vs 2).Eligibility criteria: Eligible patients are pre- or postmenopausal with HER2- ER+ bone-dominant MBC and ≥ 2 bone mets or with soft tissue and/or visceral mets, and 1-2 prior SREs (external beam radiotherapy, pathologic bone fracture, spinal cord compression, orthopedic surgery); they have received ≥ 1 line of ET for MBC and are considered appropriate for further ET. Patients must have evaluable disease (RECIST 1.1), be taking bisphosphonates or denosumab for ≥ 1 month before study treatment, have an ECOG score 0-1, and have adequate hematologic, renal, and liver function. Patients must not have had visceral or brain mets or leptomeningeal disease, or need chemotherapy for MBC, and must not be suitable for everolimus for MBC. Patients are not eligible if they had prior radium-223 treatment or have untreated spinal cord compression.Specific aims: The primary end point is SSE-free survival (SSE-FS). Secondary end points are radiologic progression-free survival; overall survival; times to op...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Ongoing Clinical Trials Source Type: research