a study on Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
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
OUTLINE: This is a multicenter study. Patients are stratified according to risk level (node-negative and recurrence score [RS]> 25 in the primary tumor, and a tumor measuring ≥ 2 cm in greatest diameter treated with adjuvant therapy vs 1-3 positive lymph nodes and RS> 25 treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] prior to or after neoadjuvant chemotherapy). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Men receive tamoxifen citrate PO for 5 years.
NOTE: **Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
Blood and tissue samples are collected for biomarker studies.
After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 10 years.
Breast Cancer estrogen receptor-positive breast cancer HER2-negative breast cancer stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer progesterone receptor-positive breast cancer male breast cancer Hormones Letrozole Exemestane Anastrozole Everolimus Sirolimus Tamoxifen Leuprolide Goserelin Citric Acid
For people ages 18 years and up
HER2 is negative if a single test (or all tests) performed in a tumor specimen show:
ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+.
HER2 equivocal is not eligible.
PRIOR CONCURRENT THERAPY:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT01674140.
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