Titre |
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 |
Protocole ID |
EPIK-B2 |
ClinicalTrials.gov ID |
NCT04208178 |
Type(s) de cancer |
Sein |
Phase |
Phase III |
Médicament |
Alpelisib en association avec trastuzumab et pertuzumab |
Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
HOPITAL DU SAINT-SACREMENT
1050 Ch Ste-Foy, Québec, QC, G1S 4L8
|
Ville |
Québec |
Investigateur(trice) principal(e) |
Dre Catherine Doyle
|
Coordonnateur(trice) |
Judith-Élise Marcoux
418-525-4444 poste 84577
|
Statut |
Fermé |
Critètes d'éligibilité |
- 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.
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Critètes d'exclusion |
- 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.
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