drugset / Trial / NCT01674140
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Phase 3
Active not recruiting
1939 enrolled
SWOG Cancer Research Network
National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2013-09-12
- Primary completion
- 2022-12-01
- Completion
- 2030-01
Publications
- Pusztai L, Hoag JR, Albain KS, Barlow WE, Stemmer SM, Meisner A, Hortobagyi GN, Shak S, Rae JM, Baehner R, Sharma P, Kalinsky KM. Development and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor-Positive, Node-Positive Breast Cancer. J Clin Oncol. 2025 Mar 10;43(8):919-928. doi: 10.1200/JCO-24-01507. Epub 2024 Dec 2.
- Chavez-MacGregor M, Miao J, Pusztai L, Goetz MP, Rastogi P, Ganz PA, Mamounas EP, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber ALM, Flaum LE, Andreopoulou E, Wendt AG, Carney JF, Sharma P, Gralow JR, Lew DL, Barlow WE, Hortobagyi GN. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy +/- 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive, Early-Stage Breast Cancer. J Clin Oncol. 2024 Sep 1;42(25):3012-3021. doi: 10.1200/JCO.23.02344. Epub 2024 Jun 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Background | Anastrozole | Other / unclassified | — | Oral |
| Background | Exemestane | Small molecule | — | Oral |
| Background | Goserelin | Other / unclassified | — | Subcutaneous |
| Background | Letrozole | Other / unclassified | — | Oral |
| Background | Leuprolide | Other / unclassified | — | Subcutaneous |
| Background | Tamoxifen | Small molecule | — | Oral |