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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

NCT ID: NCT04251533

Last Updated: 2025-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2026-01-13

Brief Summary

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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)

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Detailed Description

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The recruitment of Part A was halted on 11-Nov-2022 due to slow recruitment. Since Part B1 did not meet its primary objective for confirmed overall response rate, the Part B2 was not initiated, and the recruitment was halted for the entire study.

Upon confirming either PIK3CA mutation and/or PTEN loss status, advanced TNBC participants meeting all other eligibility criteria were assigned to either Part A (PIK3CA mutation regardless of PTEN loss) or Part B1 (PTEN loss with PIK3CA unknown or non-mutant).

In Part A, participants were randomized a 1:1 to receive either:

* alpelisib 300 mg daily orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle or
* placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.

In Part B1, participants received alpelisib 300 mg daily orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.

Conditions

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Triple Negative Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: alpelisib + nab-paclitaxel

Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle

Group Type EXPERIMENTAL

alpelisib

Intervention Type DRUG

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

nab-paclitaxel

Intervention Type DRUG

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

Part A: placebo + nab-paclitaxel

Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

nab-paclitaxel

Intervention Type DRUG

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

Part B1: alpelisib + nab-paclitaxel

Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.

Group Type EXPERIMENTAL

alpelisib

Intervention Type DRUG

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

nab-paclitaxel

Intervention Type DRUG

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

Interventions

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alpelisib

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

nab-paclitaxel

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

Intervention Type DRUG

Other Intervention Names

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BYL719 alpelisib-matching placebo abraxane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of California LA

Los Angeles, California, United States

Site Status

Hematology and Oncology Clinic

Baton Rouge, Louisiana, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Park Nicollet Institute

Saint Louis Park, Minnesota, United States

Site Status

SCRI Oncology Partners

Nashville, Tennessee, United States

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Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

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Novartis Investigative Site

CABA, , Argentina

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Novartis Investigative Site

Melbourne, Victoria, Australia

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Novartis Investigative Site

Nedlands, Western Australia, Australia

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Innsbruck, Tyrol, Austria

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Leoben, , Austria

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Novartis Investigative Site

Barretos, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Novartis Investigative Site

Plovdiv, , Bulgaria

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Hefei, Anhui, China

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Shijiazhuang, Hebei, China

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Changsha, Hunan, China

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Nanjing, Jiangsu, China

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Nanchang, Jiangxi, China

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Changchun, Jilin, China

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Shengyang, Liaoning, China

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Shenyang, Liaoning, China

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Chengdu, Sichuan, China

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Hangzhou, Zhejiang, China

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Dalian, , China

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Shanghai, , China

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Tianjin, , China

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Bogotá, , Colombia

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Zagreb, , Croatia

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Saint-Cloud, Hauts De Seine, France

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Angers, , France

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Saint-Herblain, , France

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Villejuif, , France

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Essen, , Germany

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Budapest, , Hungary

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Faridabad, Haryana, India

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Mumbai, Maharashtra, India

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Vellore, Tamil Nadu, India

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Hyderabad, Telangana, India

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Tel Aviv, , Israel

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Meldola, FC, Italy

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Roma, RM, Italy

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Napoli, , Italy

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Petaling Jaya, Selangor, Malaysia

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Opole, , Poland

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Poznan, , Poland

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Arkhangelsk, , Russia

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Chelyabinsk, , Russia

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Moscow, , Russia

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Istanbul, Kadikoy, Turkey (Türkiye)

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Nottingham, , United Kingdom

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Oxford, , United Kingdom

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Kuala Lumpur, , Malaysia

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Monterrey, Nuevo León, Mexico

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Oslo, , Norway

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Trujillo, La Libertad, Peru

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Novartis Investigative Site

Gdynia, , Poland

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Moscow, , Russia

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Saint Petersburg, , Russia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Ljubljana, , Slovenia

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Port Elizabeth, Western Cape, South Africa

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Johannesburg, , South Africa

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Palma, Balearic Islands, Spain

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Badajoz, Extremadura, Spain

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Alicante, , Spain

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Lausanne, , Switzerland

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Novartis Investigative Site

Taipei, , Taiwan

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Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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United States Argentina Australia Austria Brazil Bulgaria China Colombia Croatia France Germany Hungary India Israel Italy Malaysia Mexico Norway Peru Poland Russia Slovakia Slovenia South Africa South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-002637-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBYL719H12301

Identifier Type: -

Identifier Source: org_study_id

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