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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

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

View Map

Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183093

Date Last Changed: July 17, 2013


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