ACTIVE_NOT_RECRUITING

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility. All patients must have HER2 negative breast cancer with the identified PIK3CA mutation and received at least one line of endocrine therapy. The study will consist of a screening phase, a treatment phase, and a post-treatment phase which includes safety, efficacy, and follow-up. The treatment phase will include taking alpelisib daily in combination with continued use of either Fulvestrant or Aromatase Inhibitor per standard of care until disease progression or unacceptable toxicity.

Official Title

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Quick Facts

Study Start:2021-02-12
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04762979

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Marina N Sharifi, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Illinois Cancer Center
Chicago, Illinois, 60612
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Marina N Sharifi

  • Marina N Sharifi, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-12
Study Completion Date2026-05

Study Record Updates

Study Start Date2021-02-12
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Hormone Receptor Positive Breast Carcinoma
  • HER2-negative Breast Cancer
  • PIK3CA Mutant Metastatic Breast Cancer