A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Summary:
The purpose of the study is to evaluate whether early local therapy of intact primary disease in subjects with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to those who receive local therapy for palliation only.

Growing evidence suggests that there is molecular communication between the primary tumor and the pre metastatic niche. Secretion of growth factors, proliferation factors, and stimulatory signals starting from the primary tumor may play a role in the growth of the metastatic lesion.

Data from other tumor types point to a possible survival advantage for patients with distant metastases undergoing resection of the primary tumor. A retrospective analysis of patients with asymptomatic primary colon cancer and distant metastases experienced longer survival following primary tumor resection.

Eligibility and Treatment Plan:
Age 18 or older
Male or female
Diagnosed with intact primary (not recurrent) invasive carcinoma of the breast
At least one site of distant metastatic disease

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