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EPIK-B3: A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation - CBYL719H12301 - AIOM
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EPIK-B3: A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation - CBYL719H12301

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Prima linea, Seconda linea

Criteri di inclusione: 

- Subject has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC
- Subject has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: patients must have measurable disease
- Subject has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B - PTEN loss without a PIK3CA mutation
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subject has received no more than one line of therapy for metastatic disease.
- Subject has adequate bone marrow and organ function

Criteri di esclusione: 

- Subject has received prior treatment with any PI3K, mTOR or AKT inhibitor
- Subject has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients
- Subject has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia
- Subject has central nervous system (CNS) involvement
- Subject with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c
- Subject has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion
- Subject has a history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
- Subject has currently documented pneumonitis/interstitial lung disease
- Subject has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS)
- Subject with unresolved osteonecrosis of the jaw
Other protocol-defined inclusion/exclusion criteria apply.

Trattamento sperimentale: 

alpelisib + nab-paclitaxel
Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Single arm Open label in Study Part B1

Trattamento di controllo: 

placebo + nab-paclitaxel
Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Not applicable in Study Part B1

Obiettivi primari dello studio: 

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2).

Note generali: 

Lo studio è attivo anche nelle seguenti città:

- Ancona (CAP 60126),
- Messina (CAP 98158),
- Roma (CAP 00128),
- Napoli (CAP 80131).

Centri partecipanti

Nord Italia

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Ugo De Giorgi
Telefono: 0543739100
Email: ugo.degiorgi@irst.emr.it

 

Sud Italia e isole

IRCCS CROB
Via Padre Pio 1 - 85028 Rionero In Vulture - PZ

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-002637-11

Data di inserimento: 19.03.2021

Promotore

Novartis

CRO

NA

Principal Investigator ITALIA

Riferimento: Dr. non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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