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COMPLETED
NCT02860000
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: MC1431 Randomized Phase II Trial to Evaluate Alisertib Alone or Combined With Fulvestrant for Women With Advanced, Endocrine-Resistant Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2017-07-06

Completion Date

2025-02-14

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DRUG

Alisertib

Given PO

DRUG

Fulvestrant

Given IM

OTHER

Laboratory Biomarker Analysis

Correlative studies

Locations (8)

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States