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Study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation
EU CTIS ID: 2024-512050-13-00
What this study is testing
Safety run-in Part 1: To confirm the Recommended Phase 3 Dose of alpelisib in combination with trastuzumab and pertuzumab Double-blind, randomized, placebo-controlled Part 2: To determine whether treatment with alpelisib in combination with trastuzumab and pertuzumab prolongs PFS compared to placebo in combination with trastuzumab and pertuzumab in adult participants with HER2-positive advanced breast cancer with a PIK3CA mutation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally recurrent not amenable to surgery or 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. A minimum of 4 cycles of induction therapy is permitted if discontinuation of taxane was due to taxane toxicity.
- 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 tissue prior to enrollment, as determined by a Novartis designated central laboratory.
You likely can't join if
- Participant with inflammatory breast cancer at screening.
- Participant with evidence of disease progression during or following completion of 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 not controlled 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), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS).
See the full eligibility criteria
- Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally recurrent not amenable to surgery or 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. A minimum of 4 cycles of induction therapy is permitted if discontinuation of taxane was due to taxane toxicity.
- 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 tissue prior to enrollment, as determined by a Novartis designated central laboratory.
- Participant with inflammatory breast cancer at screening.
- Participant with evidence of disease progression during or following completion of 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 not controlled 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), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS).
- Participant has currently documented pneumonitis/interstitial lung disease
The study team makes the final eligibility decision.
Where it's taking place
- Malaysia
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malaysia; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.