Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
Trial Parameters
Brief Summary
Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.
Eligibility Criteria
Inclusion Criteria: * Female sex * ≥ 18 years of age * Histologically confirmed invasive breast cancer, with oligometastatic disease defined as one of the following criteria: 1) One to four bone lesions; 2) One to four lung and/ or hepatic lesions; 3) Distant metastasis limited to ipsilateral cervical lymph nodes; 4) Distant metastasis limited to contralateral axillary lymph nodes * Oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablation * Estrogen receptor-positive and/ or progesterone receptor-positive breast cancer * Partial response or stable disease after at least six months of systemic therapy for breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Measurable or non-measuble disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Life expectancy of at least 12 weeks * For women in childbearing age, negative pregnancy tes