Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Advanced HER2+Breast Cancer

In brief

The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.

Key facts

Study ID

NCT04208178

Run by

Novartis Pharmaceuticals

People needed

19

Starts

2020-07-16

Expected to finish

2027-02-26

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic).
• Participant has received pre-study induction therapy with up to and including a maximum of 8 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. 4 or 5 cycles of induction therapy are permitted if discontinuation of taxane was due to taxane toxicity. Of note, participants enrolled in Part 1 of this study received 4-6 cycles of pre-study induction therapy.
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Participant has adequate bone marrow and organ function
• Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or as determined by a Novartis designated central laboratory.

You may not qualify if…

• Participant with inflammatory breast cancer at screening.
• Participant with evidence of disease progression during the pre-study induction therapy and prior to first dose of alpelisib (or alpelisib/alpelisib matching-placebo for Part 2)
• Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c.
• Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
• Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events
• Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN).
• Participant has currently documented pneumonitis/interstitial lung disease
• Other protocol-defined Inclusion/Exclusion may apply.

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• University of California LA — Los Angeles, California, United States
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Changchun, Jilin, China
• Novartis Investigative Site — Shanghai, China
• Novartis Investigative Site — Saint-Cloud, Hauts De Seine, France
• Novartis Investigative Site — Saint-Herblain, France
• Novartis Investigative Site — Florence, FI, Italy
• Novartis Investigative Site — Kuala Lumpur, Malaysia
• Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona, Spain

Full record on ClinicalTrials.gov

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