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Breast Cancer (BYLieve)

A Phase II Clinical Study for Patients with HR+, HER2-negative Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed On or After Prior Treatments

Overview

This Study Is Recruiting: Phase II Actual Start Date: [August 14, 2017] Estimated Completion Date: [November 30, 2021] Novartis Reference Number: CBYL719X2402
Condition: Breast Cancer Interventions: Alpelisib (BYL719), fulvestrant, letrozole, goserelin, leuprolide Estimated Enrollment: [340 participants] ClinicalTrials.gov Identifier: NCT03056755
This Study Is Recruiting: Phase II Actual Start Date: [August 14, 2017]
Estimated Completion Date: [November 30, 2021] Novartis Reference Number: CBYL719X2402
Condition: Breast Cancer Interventions: Alpelisib (BYL719), fulvestrant, letrozole, goserelin, leuprolide
Estimated Enrollment: [340 participants] ClinicalTrials.gov Identifier: NCT03056755

Study Goal

Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have progressed on or after prior treatments.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

Participants may be eligible to participate if they:

  • Are a premenopausal or postmenopausal woman or a man aged 18 years or older
  • Have been diagnosed with HR+, HER2- advanced or metastatic breast cancer
  • Have a confirmed PIK3CA mutation
  • Have cancer that has recurred or progressed during or after CDK 4/6 inhibitor combination therapy (as the last treatment regimen prior to study entry)
    • OR have prior aromatase inhibitor treatment (either in adjuvant or metastatic setting) and received systemic chemotherapy or endocrine therapy as last therapy for cohort C
  • Meet other eligibility criteria

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Definitions:
aBC – Advanced or metastatic breast cancer, CDK 4/6 - Cyclin-dependent kinase 4/Cyclin-dependent kinase 6, HER2 - Human epidermal growth factor receptor 2, HR - Hormone receptor, ICF - Informed consent form, PIK3CA - Phosphoinositide 3-kinase alpha

Last Updated: July 18, 2019

8/19 M-GON-1216067