Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery

Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery.

Timeline

Start

2008-04

Primary completion

2013-01

Completion

—

Outcome

Missed primary endpoint

Stopped (Enrollment): “IDMC decision due to accrual issue (82 pts accrued / 120 expected)”

paper The addition of everolimus did not improve the efficacy, but induced MAPK signalling. PMID 34678678 ↗

Publications

• Campone M, Bachelot T, Treilleux I, Pistilli B, Salleron J, Seegers V, Arnedos M, Loussouarn D, Wang Q, Vanlemmens L, Jimenez M, Rios M, Dieras V, Leroux A, Paintaud G, Rezai K, Andre F, Lion M, Merlin JL. A phase II randomised study of preoperative trastuzumab alone or combined with everolimus in patients with early HER2-positive breast cancer and predictive biomarkers (RADHER trial). Eur J Cancer. 2021 Nov;158:169-180. doi: 10.1016/j.ejca.2021.09.017. Epub 2021 Oct 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	10 mg	Oral
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous

Indications