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SWOG S1207 (Invasive Breast Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if giving the study drug Everolimus with hormone therapy is better than hormone therapy by itself.

What is the Condition Being Studied?

Invasive Breast Cancer

Who Can Participate in the Study?

Adults with invasive breast carcinoma who:
- Have completed breast conserving surgery or total mastectomy
- Have completed chemotherapy
- Are not pregnant or nursing

Age Group
Adults

What is Involved?

If choose to join this study, you will:
- Be randomized (like the flip of a coin) to get either:
-- Group 1: Standard hormone treatment plus a placebo (a pill with no medicine) for up to 1 year
-- Group 2: Standard hormone treatment plus the study drug Everolimus for up to 1 year
- Be followed up with clinic visits every 6 months for 2 years and then yearly for up to 10 years

Study Details

Full Title
SWOG S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/NEU Negative Breast Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00060455
NCT:NCT01674140
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698