Home Breast Cancer The MONALEESA-7 Hormone Receptor-Positive Breast Cancer Clinical Study

The MONALEESA-7 Hormone Receptor-Positive Breast Cancer Clinical Study

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Onclive offers a video hearing from Dr. Debu Tripathy, MD, professor and chairman, Department of Breast Medical Oncology, Division of Cancer Medicine, the University of Texas MD Anderson  Cancer Center, discuss the MONALEESA-7 trial in hormone receptor-positive breast cancer.  The research is leading to advancements for women. For example, young women afflicted with a common form of advanced breast cancer are being treated with drugs that target cancer cells. Their survival rates are improving.

The Study

The study is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer. The study was designed to help assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer.

This study was conducted among 672 women younger than 59 who received a drug called ribociclib, in combination with a common form of hormone therapy.   72% of the women who were on the combination therapy were alive after 42 months; this was compared to the 46% for women who were treated only with hormone therapy and placebo.  The research indicates that there is a 29% lower risk of death in the patients receiving the combination therapy.  Published in the New England Journal of Medicine, the results were presented at ASCO.

The study’s lead author, Dr. Sara Hurvitz, emphasized that this study is the first to show a significant benefit in survival for premenopausal women with metastatic hormone-receptor positive breast cancer.

The Drug

Novartis’ Ribociclib (Kisqali)  is an inhibitor of cyclin D1/CDK4 and CDK6 and is used for the treatment of certain kinds of breast cancer. It is also being studied as a treatment for other drug-resistant cancers. Developed by Novartis and Astex Pharmaceuticals.

Industry Sponsor

Novartis funded the study. The drug is taken in pill form. It costs over $12,000 a month, according to the prescription price GoodRX.

Breast Cancer

In 2019 alone nearly 630,000 women will die from breast cancer worldwide, representing 15% of all cancer deaths among women according to the World Health Organization. It is the most common cancer in women in the United States, with about 41,000 women and 450 men who will die each year from breast cancer according to the Centers for Disease Control

Lead Research/Investigator

Dr. Sara Hurvitz, director Breast Cancer Clinical Research Program, UCLA Jonsson Comprehensive Cancer Center.

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