Title A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
IRB ECOG 2108
Hospital Florida Weston
Stage Stage 4
Phase Phase 3
To evaluate whether early local therapy of intact primary disease in patients with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to patients who receive local therapy for palliation only.
- To compare the time to uncontrolled chest wall disease between patients who receive early local therapy versus patients who receive palliative local therapy.
- To determine whether there is a difference in HRQL between patients who receive early local therapy and those who receive palliative local therapy.
- To determine whether the absolute value of the CTC burden at six months following randomization will be lower in Arm B than Arm A and whether this value is inversely related to survival.
- To collect tumor and blood specimens for future exploration of the biological interactions between the primary tumor and metastatic lesions and the effect of primary tumor resection.