New triple therapy aims to halt advanced breast cancer

NCT ID NCT01872260

Ongoing Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two experimental drugs (LEE011 and BYL719) plus a standard hormone therapy (letrozole) in about 255 women with advanced ER+ breast cancer. The goal is to find safe doses and see if the triple combination can better control the cancer. Participants must have ER+ or PR+ tumors and have had limited prior treatments.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER

Contacts and locations

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Locations

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Massachusetts General Hospital SC-5

Boston, Massachusetts, 02114, United States
Mays Cancer Ctr Uthsa Mdacc

San Antonio, Texas, 78229, United States
Northwest Medical Specialties

Tacoma, Washington, 98405, United States
Novartis Investigative Site

Westmead, New South Wales, 2145, Australia
Novartis Investigative Site

Parkville, Victoria, 3050, Australia
Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia
Novartis Investigative Site

Marseille, 13273, France
Novartis Investigative Site

Paris, 75475, France
Novartis Investigative Site

Saint-Herblain, 44805, France
Novartis Investigative Site

Pisa, PI, 56126, Italy
Novartis Investigative Site

Seoul, 03080, South Korea
Novartis Investigative Site

Madrid, 28009, Spain
Novartis Investigative Site

Madrid, 28050, Spain
Novartis Investigative Site

Seville, 41013, Spain
Novartis Investigative Site

Valencia, 46010, Spain
Novartis Investigative Site

Bellinzona, 6500, Switzerland
Novartis Investigative Site

Glasgow, G12 0YN, United Kingdom
Novartis Investigative Site

Manchester, M20 2BX, United Kingdom
Tennessee Oncology

Nashville, Tennessee, 37203, United States
Texas Oncology

Amarillo, Texas, 79124, United States
UCSF Medical Center

San Francisco, California, 94143, United States
Univ of California at San Diego Moores Cancer Ctr

San Diego, California, 92103, United States
Vanderbilt University Medical Ctr

Nashville, Tennessee, 37232, United States

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