Status and phase
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About
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.
Enrollment
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Inclusion and exclusion criteria
Eligibility Criteria Individuals from populations who are underrepresented in clinical research (e.g., racial and ethnic minorities, women, individuals from rural/frontier communities, older individuals) will be enrolled with a goal of ensuring that all eligible patients are given the opportunity to participate in novel clinical trials and that research findings can be generalizable to the entire population.
Inclusion Criteria
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-2 within 28 days prior to registration.
Men and postmenopausal female patients. Premenopausal patients (age 18 or older) who have been rendered postmenopausal will also be included. Postmenopausal is defined as:
NOTE: Women who do not fit the criteria for being postmenopausal as above are deemed premenopausal. Premenopausal patients (age 18 or older) who can be rendered postmenopausal will also be eligible. Methods eligible for rending premenopausal patients postmenopausal include:
Exclusion Criteria
NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) within 28 days prior to registration to exclude brain metastases.
Treatment with any investigational drug within 14 days prior to registration.
Radiotherapy to index lesion <= 4 weeks or limited field radiation to index lesion for palliation <= 2 weeks prior to randomization.
Established diagnosis of diabetes mellitus type I or persistent poorly controlled diabetes mellitus, with an uninterrupted hemoglobin A1c > 8.0% for 1 year or greater despite standard care. For patients with newly diagnosed diabetes mellitus without 1 year of hemoglobin A1c values, available hemoglobin A1c values cannot all be > 8.0%.
Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
As determined by the enrolling physician or protocol designee, impairment of gastrointestinal function or disease that may significantly alter the absorption of the study drugs.
Currently documented clinically active pneumonitis. Patients could have received prior treatment for pneumonitis but pneumonitis must have clinically resolved and treatments for pneumonitis (e.g. steroids) must be completed prior to randomization.
Active cardiac disease, defined as any of the following within 6 months prior to the start of study treatment:
History of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis.
Prior treatment with PI3K, mTOR or AKT inhibitor in the metastatic setting.
History of chronic steroid use (defined as daily steroid use > 14 days) and requirement for continued chronic steroid use.
Primary purpose
Allocation
Interventional model
Masking
44 participants in 1 patient group
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Central trial contact
Marina N Sharifi, MD, PhD; Milena Petkov
Data sourced from clinicaltrials.gov
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