Trial Information

ECOG E2108 Phase III Randomized Study of Early Local Therapy Comprising Surgery Versus Standard Palliative Therapy for the Intact Primary Tumor in Patients With Stage IV Breast Cancer

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.

Patient Inclusion Criteria:

age >18 years of age
Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast
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
Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)
Prior non-invasive (DCIS) cancer allowed provided there has been no recurrence
Prior ipsilateral invasive cancer allowed if more than 5 years previous

Patient Exclusion Criteria:

No synchronous contralateral breast cancer
Patients should have at least one organ system involved with distant metastatic disease
If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy
CNS metastases allowed provided projected survival > 6 months

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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