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

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer (IRB 011-228)

Study Description:

The purpose of this study is to evaluate whether early local therapy comprising surgery of intact primary disease compared to local palliative therapy only in patients with stage IV breast cancer, whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival.

Inclusion Criteria:

» Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast: Stage IV disease; Confirmation of the primary tumor should be by needle biopsy (preferred); Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast
» Prior non-invasive (DCIS) cancer allowed provided there has been no recurrence
» No synchronous contralateral breast cancer
» At least 1 site of distant metastatic disease. Biopsy of a single metastatic lesion is mandatory and a pathology report confirming the diagnosis of primary breast cancer, as well as metastatic site, must be available.
» Must have available radilogic reports documenting disease status within the past 4 weeks prior to initiating systemic therapy.
» CNS metastases allowed provided projected survival > 6 months.
» Patients must have completed 16 weeks of systemic therapy with < 2 weeks of unscheduled dose interruption.
» No evidence of disease progression (by radiographic documentation) prior to and within 2 weeks of randomization, including the following: No new sites of disease; No enlargement of existing sites by 20% or more in longest diameter; No symptomatic deterioration
» Local disease at the primary site must be asymptomatic (no skin nodules or skin invasion, no ulceration, and no chest wall fixation)
» Hormone receptor status known
» See Disease Characteristics
» Menopausal status not specified
» Candidate for complete resection with free margins followed by radiotherapy
» More than 5 years since other primary cancers that were curatively treated
» Not pregnant or nursing
» Negative pregnancy test
» Fertile patients must use an accepted and effective contraception method
» See Disease Characteristics

Exclusion Criteria:



Baylor Medical Center at Irving
Irving Cancer Center
2001 N. MacArthur Blvd.
Irving , TX 75061

Lead Principal Investigator:

Sarju Waghela, MD

For further information regarding this study, please contact the Office of Clinical Oncology Research Coordination at 214-818-8472 or via email at

Last update: July 24, 2012