Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients

Summary

This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2 (HER2)-positive breast cancer or other solid tumors that have spread to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by tumor cells. Immunotherapy with monoclonal antibodies, such as trastuzumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving everolimus, letrozole, and trastuzumab together may be a better treatment for breast cancer and other solid tumors than everolimus alone.

Timeline

Start

2014-07-17

Primary completion

2020-12-14

Completion

2020-12-14

Publications

• Ballhausen A, Wheler JJ, Karp DD, Piha-Paul SA, Fu S, Pant S, Tsimberidou AM, Hong DS, Subbiah V, Holley VR, Huang HJ, Brewster AM, Koenig KB, Ibrahim NK, Meric-Bernstam F, Janku F. Phase I Study of Everolimus, Letrozole, and Trastuzumab in Patients with Hormone Receptor-positive Metastatic Breast Cancer or Other Solid Tumors. Clin Cancer Res. 2021 Mar 1;27(5):1247-1255. doi: 10.1158/1078-0432.CCR-20-2878. Epub 2020 Oct 28.

Drugs

Indications