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NCT04251533

PHASE3

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study was 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 (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

137

Start Date

2020-06-08

Completion Date

2026-02-05

Last Updated

2026-04-30

Healthy Volunteers

Conditions

Triple Negative Breast Neoplasms

Interventions

DRUG

alpelisib

300 mg orally, once per day (QD), tablets

DRUG

placebo

300 mg orally, once per day (QD), tablets

DRUG

nab-paclitaxel

100 mg/m\^2 IV infusion, once per day (QD)

Inclusion Criteria: * Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC * Participant 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: Participants must have measurable disease * Participant 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 B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participant has received no more than one line of therapy for metastatic disease * Participant has adequate bone marrow and organ function Exclusion Criteria: * Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor * Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients * Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia * Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening * Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c * Participant 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 * Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis * Participant has currently documented pneumonitis/interstitial lung disease * Participant 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) * Participant with unresolved osteonecrosis of the jaw

Locations (78)

University of California LA

Los Angeles, California, United States

Hematology and Oncology Clinic

Baton Rouge, Louisiana, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Park Nicollet Institute

Saint Louis Park, Minnesota, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Nedlands, Western Australia, Australia

Novartis Investigative Site

Innsbruck, Tyrol, Austria

Novartis Investigative Site

Leoben, Austria

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Plovdiv, Bulgaria

Novartis Investigative Site

Hefei, Anhui, China

Novartis Investigative Site

Shijiazhuang, Hebei, China

Novartis Investigative Site

Changsha, Hunan, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Nanchang, Jiangxi, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Shengyang, Liaoning, China

Novartis Investigative Site

Shenyang, Liaoning, China

Novartis Investigative Site

Chengdu, Sichuan, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Dalian, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Bogotá, Colombia

Novartis Investigative Site

Zagreb, Croatia

Novartis Investigative Site

Saint-Cloud, Hauts De Seine, France

Novartis Investigative Site

Angers, France

Novartis Investigative Site

Saint-Herblain, France

Novartis Investigative Site

Villejuif, France

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Faridabad, Haryana, India

Novartis Investigative Site

Mumbai, Maharashtra, India

Novartis Investigative Site

Vellore, Tamil Nadu, India

Novartis Investigative Site

Hyderabad, Telangana, India

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Meldola, FC, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Petaling Jaya, Selangor, Malaysia

Novartis Investigative Site

Kuala Lumpur, Malaysia

Novartis Investigative Site

Monterrey, Nuevo León, Mexico

Novartis Investigative Site

Oslo, Norway

Novartis Investigative Site

Trujillo, La Libertad, Peru

Novartis Investigative Site

Gdynia, Poland

Novartis Investigative Site

Opole, Poland

Novartis Investigative Site

Poznan, Poland

Novartis Investigative Site

Arkhangelsk, Russia

Novartis Investigative Site

Chelyabinsk, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Košice, Slovakia

Novartis Investigative Site

Ljubljana, Slovenia

Novartis Investigative Site

Port Elizabeth, Western Cape, South Africa

Novartis Investigative Site

Johannesburg, South Africa

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Palma, Balearic Islands, Spain

Novartis Investigative Site

Badajoz, Extremadura, Spain

Novartis Investigative Site

Alicante, Spain

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Kadikoy, Turkey (Türkiye)

Novartis Investigative Site

Nottingham, United Kingdom

Novartis Investigative Site

Oxford, United Kingdom

Clinical Research Directory

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (78)