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Fulvestrant

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Subjects will be treated with Alpelisib in combination with either an Aromatase Inhibitor or Fulvestrant per Standard of Care

Alpelisib 300mg, PO, days 1-28 of each cycle.

Alpelisib

Aromatase Inhibitor, administered per standard of care

Aromatase inhibitor

Marina N Sharifi, MD, PhD

Milena Petkov

Roxana Toh

Oana Danciu, MD

Tamara Braley

Jairam Krishnamurthy, MD

CI-CTO REG Penn State

Cristina Truica, MD

Marina N Sharifi, MD

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.

Apelisib 300mg PO, Daily AND Aromatices Inhibitor(AI) or Fulvestrant 500mg IM per Standard of Care

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

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

To estimate the progression-free survival (PFS) of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. PFS defined as time from D1 of treatment with alpelisib with endocrine therapy.

To estimate the objective response rate (ORR) of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. ORR will include confirmed complete response (CR) and confirmed partial response (PR) as determined by RECIST 1.1

To estimate the clinical benefit rate (CBR) of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. CBR will include the sum of CR + PR + stable disease (SD) on treatment with alpelisib with endocrine therapy.

To estimate the duration of response (DoR) of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. DOR is defined as the time that measurement criteria are met CR or PR (whichever status is recorded first) until the date that recurrent or progressive disease PD) is objectively documented.

To estimate the overall survival (OS) of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. OS is defined as the time from treatment initiation with alpelisib with endocrine therapy following progression until death as a result of any cause.

To estimate grade 3-4 adverse events or events of any grade leading to dose adjustments of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. Grade 3-4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 or events of any grade leading to dose adjustments.

Spots Global Cancer Trial Database for pik3ca mutant metastatic breast cancer