Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

Summary

This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.

Timeline

Start

2017-07-06

Primary completion

2022-01-10

Completion

2025-02-14

Outcome

Missed primary endpoint

paper The ORR was 19.6%; (90% CI, 10.6%-31.7%) for arm 1 and 20.0% (90% CI, 10.9%-32.3%) for arm 2. PMID 36892847 ↗

paper This randomized clinical trial found that adding fulvestrant to treatment with alisertib did not increase ORR or PFS PMID 36892847 ↗

Publications

• Haddad TC, Suman VJ, D'Assoro AB, Carter JM, Giridhar KV, McMenomy BP, Santo K, Mayer EL, Karuturi MS, Morikawa A, Marcom PK, Isaacs CJ, Oh SY, Clark AS, Mayer IA, Keyomarsi K, Hobday TJ, Peethambaram PP, O'Sullivan CC, Leon-Ferre RA, Liu MC, Ingle JN, Goetz MP. Evaluation of Alisertib Alone or Combined With Fulvestrant in Patients With Endocrine-Resistant Advanced Breast Cancer: The Phase 2 TBCRC041 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):815-824. doi: 10.1001/jamaoncol.2022.7949.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alisertib	Small molecule	—	Oral
Subject	Fulvestrant	Small molecule	—	Intramuscular

Indications