Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

Summary

This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

Timeline

Start

2011-02-28

Primary completion

2023-02-01

Completion

2027-01-08

Publications

• Abdou Y, Hoag J, Barlow WE, Albain KS, Gralow JR, Meric-Bernstam F, Hayes DF, Lin NU, Perez EA, Goldstein LJ, Chia SKL, Dhesy-Thind S, Rastogi P, Schott AF, Racz J, Baehner FL, Tripathy D, Hortobagyi GN, Pusztai L, Sharma P, Kalinsky K. Recurrence Score(R) gene group components and outcomes in the RxPONDER trial (SWOG S1007). J Natl Cancer Inst. 2026 Jul 15:djag221. doi: 10.1093/jnci/djag221. Online ahead of print.
• Kang IM, Forschmiedt JK, Loch MM, Lew DL, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, Lin NU, Perez EA, Goldstein LJ, Rastogi P, Schott AF, Baehner R, Sharma P, Tripathy D, Pusztai L, Hortobagyi GN, Kalinsky K, Henry NL. Cognitive Impairment and Chemoendocrine vs Endocrine Therapy in Pre- and Postmenopausal Women: A Secondary Analysis of the RxPONDER Randomized Clinical Trial. JAMA Oncol. 2026 Feb 1;12(2):159-166. doi: 10.1001/jamaoncol.2025.5220.
• Abdou Y, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, Lin NU, Perez EA, Goldstein LJ, Chia SKL, Dhesy-Thind S, Rastogi P, Alba E, Delaloge S, Schott AF, Shak S, Sharma P, Lew DL, Miao J, Unger JM, Tripathy D, Hortobagyi GN, Pusztai L, Kalinsky K. Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial. J Natl Cancer Inst. 2025 May 1;117(5):889-897. doi: 10.1093/jnci/djae314.
• Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, Lin NU, Perez EA, Goldstein LJ, Chia SKL, Dhesy-Thind S, Rastogi P, Alba E, Delaloge S, Martin M, Kelly CM, Ruiz-Borrego M, Gil-Gil M, Arce-Salinas CH, Brain EGC, Lee ES, Pierga JY, Bermejo B, Ramos-Vazquez M, Jung KH, Ferrero JM, Schott AF, Shak S, Sharma P, Lew DL, Miao J, Tripathy D, Pusztai L, Hortobagyi GN. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. N Engl J Med. 2021 Dec 16;385(25):2336-2347. doi: 10.1056/NEJMoa2108873. Epub 2021 Dec 1.

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Indications