Informations générales (source: ClinicalTrials.gov)
EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled 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 (EPIK-B2)
Interventional
Phase 3
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
juillet 2020
juin 2026
03 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Delphine COCHEREAU | 29/03/2024 01:30:05 | Contacter | ||
| CLCC INSTITUT CURIE | 10/04/2025 13:12:16 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:11:59 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 92210 - Saint-Cloud - Hauts De Seine - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- 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.