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

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

ClinicalTrials.gov Identifier: NCT04251533

Novartis Reference Number: CBYL719H12301

Last Update: Sep 07, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

Condition 
Triple Negative Breast Neoplasms
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jun 08, 2020
Completion date 
Nov 12, 2027
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
alpelisib
300 mg orally once per day (QD)
Drug
placebo
300 mg orally once per day (QD)
Drug
nab-paclitaxel
100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle

Eligibility Criteria

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: patients 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

Other protocol-defined inclusion/exclusion criteria apply.

Study Locations

United States
Mayo Clinic Arizona
Recruiting
Phoenix, 85054 - Arizona
Contact: Jessica McKeowen (480-342-2545) - [email protected] - Donald W Northfelt
United States
Comprehensive Blood and Cancer Center Dept. of CBCC (2)
Recruiting
Bakersfield, 93309 - California
Contact: Nicole Ward (661-862-7158) - [email protected] - David Kanamori
United States
Cancer and Blood Specialty Clinic
Recruiting
Los Alamitos, 90720 - California
Contact: (562-735-0602) Vu Phan
United States
USC Norris Cancer Center
Recruiting
Los Angeles, 90033 - California
Contact: Sophie Miehl (323-865-3955) - [email protected] - Janice Lu
United States
UCLA Medical Center Santa Monica Location
Recruiting
Los Angeles, 90095 - California
Contact: Glaucia Vasquez (+1 310 582 4069) - [email protected] - Sara Alsterlind Hurvitz
United States
Cancer Care Associates Medical Group Center
Recruiting
Redondo Beach, 90277 - California
Contact: David Chan
United States
Florida Cancer Specialists Dept of Oncology (2)
Recruiting
Fort Myers, 33901 - Florida
Contact: Michele Hartzer (727-216-1143) - [email protected] - Sunil Gandhi
United States
Florida Cancer Specialists FL Cancer Specialists
Recruiting
Fort Myers, 33901 - Florida
Contact: Deaneda Gerhart - [email protected] - Faithlore P Gardner
United States
Florida Cancer Specialists Onc Dept
Recruiting
Fort Myers, 33901 - Florida
Contact: Jenifer Bar-Nur (561-472-1596) - [email protected] - Elizabeth Byron
United States
Florida Cancer Affiliates of Ocala
Recruiting
Ocala, 34471 - Florida
Contact: Sanjit Nirmalanandhan - [email protected] - Rama Balaraman
United States
University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2
Recruiting
Kansas City, 66160 - Kansas
Contact: Jecinta Scott (913-588-2566) - [email protected] - Priyanka Sharma
United States
Hematology and Oncology Clinic SC
Recruiting
Baton Rouge, 70809 - Louisiana
Contact: Aimee Alumbaugh - [email protected] - Michael Castine III
United States
Sinai Hospital of Baltimore Dept of Sinai Hospital - 2
Recruiting
Baltimore, 21215 - Maryland
Contact: Phyllis Bull (410-601-0960) Mayer Gorbaty
United States
Henry Ford Hospital
Recruiting
Detroit, 48202 - Michigan
Contact: Francesca Picotte (313-916-1984) - [email protected] - Vrushali Dabak
United States
Mayo Clinic Rochester Mayo - Roch.
Recruiting
Rochester, 55905 - Minnesota
Contact: Matthew Goetz (507-266-0539) - [email protected] - Roberto Leon Ferre
United States
Park Nicollet Institute Dept Onc
Recruiting
Saint Louis Park, 55416 - Minnesota
Contact: Joanna Hill (952-993-5710) - [email protected] - Dylan Zylla
United States
Renown Healthcare Systems
Recruiting
Reno, 89502 - Nevada
Contact: Lisa Lionetti Freutel (775-982-2951) - [email protected] - Lee Schwartzberg
United States
Meridian Health Systems
Recruiting
Neptune, 07753 - New Jersey
Contact: Roxanne Valasa (609-597-6011) - [email protected] - Evan Naylor
United States
Cleveland Clinic Foundation Taussig Cancer Center
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Cleveland, 44195 - Ohio
Contact: Holly Sasak (216-444-6833) - [email protected] - Megan Kruse
United States
University of Pittsburgh Cancer Institute Cancer Pavilion, 5th floor
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Pittsburgh, 15232 - Pennsylvania
Contact: Adam Brufsky
United States
Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga
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Chattanooga, 37404 - Tennessee
Contact: Kim Tucker (423-698-1844) - [email protected] - Brooke Daniel
United States
Tennessee Oncology Tennessee Oncology (3)
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Nashville, 37203 - Tennessee
Contact: Lillie Flynn (615-329-7664) - [email protected] - Denise A Yardley
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Texas Oncology, P.A. Austin
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Bedford, 76022 - Texas
Contact: Patricia Janeczko (512-421-4163) - [email protected] - Debra A Patt
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Texas Oncology PA Dallas Presbyterian Hospital SC
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Dallas, 75231 - Texas
Contact: Carly Trainor (214-265-2080) - [email protected] - Kristi J McIntyre
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Texas Oncology Texas Oncology - Denton
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Dallas, 75246 - Texas
Contact: Nieves Contreras Alcantera (+1 940 382 1022) - [email protected] - Charles Kurkul
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US Oncology US Oncology Associates
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Dallas, 75246 - Texas
Contact: Syed Hasan (703-554-6801) - [email protected] - Alina Huang
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El Paso, Texas Oncology
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El Paso, 79902 - Texas
Contact: Nicole Dean - [email protected] - Ines Sanchez-Rivera
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Texas Oncology Houston Memorial City SC
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Houston, 77024 - Texas
Contact: Nina Fru - [email protected] - Michelina Cairo
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University of Texas MD Anderson Cancer Center
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Houston, 77030 - Texas
Contact: Jennifer Childress (713-792-2921) - [email protected] - Debasish Tripathy
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Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio
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San Antonio, 78229 - Texas
Contact: Christine Korn (210-424-2610) - [email protected] - Emmalind T Aponte
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Texas Oncology Northeast Texas
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Tyler, 75702 - Texas
Contact: Penny Watkins (903-579-9867) - [email protected] - Sasha Strain
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Virginia Oncology Associates
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Norfolk, 23502 - Virginia
Contact: Evangeline Charity (757-873-9833) - [email protected] - Michael A. Danso
United States
Northwest Medical Specialties Northwest Medical - Puyallup
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Tacoma, 98405 - Washington
Contact: Emily Kerry (253-620-4234) - [email protected] - Sibel Blau
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