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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 (EPIK-B3)

Primary Purpose

Triple Negative Breast Neoplasms

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

alpelisib

placebo

nab-paclitaxel

About this trial

This is an interventional treatment trial for Triple Negative Breast Neoplasms focused on measuring Triple Negative Breast Cancer, alpelisib, BYL719, nab-paclitaxel, PIK3CA mutation, PTEN loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alpelisib + nab-paclitaxel

placebo + nab-paclitaxel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) Per Investigator Assessment in Study Part A

PFS, defined as time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1

Progression-free Survival (PFS) Per Investigator Assessment in Study Part B2

Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in Study Part B1

ORR is defined as the proportion of subjects with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1

Secondary Outcome Measures

Overall Survival (OS) in Study Part A

OS is defined as the time from date of randomization to date of death due to any cause

Overall Survival (OS) in Study Part B2

OS is defined as the time from date of randomization to date of death due to any cause

Overall response rate (ORR) with confirmed response in Study Part A

ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1

Overall response rate (ORR) with confirmed response in Study Part B2

ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1

Clinical benefit rate (CBR) with confirmed response in Study Part A

Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1

Clinical benefit rate (CBR) with confirmed response in Study Part B1

Clinical benefit rate (CBR) with confirmed response in Study Part B2

Time to response (TTR) in Study Part A

Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1

Time to response (TTR) in Study Part B1

Time to response (TTR) in Study Part B2

Duration of Response (DOR) with confirmed response in Study Part A

Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer

Duration of Response (DOR) with confirmed response in Study Part B1

Duration of Response (DOR) with confirmed response in Study Part B2

Overall Survival (OS) in Study Part B1

OS is defined as the time from date of enrolment to date of death due to any cause

Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1

PFS, defined as time from the date of enrolment to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1

Plasma concentrations of alpelisib in Study Part B2

Summary statistics of plasma alpelisib concentrations by time point

Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in Study Part B2

Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment

Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in Study Part B2

Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items & is composed of both multi-item scales & single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items & a global health status/QoL scale. The scales & single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems

PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in Study Part A

PFS in patients with PIK3CA mutation as measured in ctDNA

PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in Study Part B2

PFS in patients with PIK3CA mutation as measured in ctDNA

Time to definitive deterioration of the ECOG performance status from baseline in Study Part B2

Definitive deterioration of ECOG PS is defined as the time from the date of randomization to the date of event defined as a worsening of at least once category from baseline in ECOG PS with no later improvement above this threshold observed during the course of the treatment or until death due to any cause

Full Information

NCT ID

NCT04251533

First Posted

January 30, 2020

Last Updated

October 16, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04251533

Brief Title

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

Acronym

EPIK-B3

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 8, 2020 (Actual)

Primary Completion Date

May 31, 2023 (Actual)

Study Completion Date

March 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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)

Detailed Description

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 will not be initiated and the recruitment was halted for the entire study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Neoplasms

Keywords

Triple Negative Breast Cancer, alpelisib, BYL719, nab-paclitaxel, PIK3CA mutation, PTEN loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

alpelisib + nab-paclitaxel

Arm Type

Experimental

Arm Description

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

Arm Title

placebo + nab-paclitaxel

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

alpelisib

Other Intervention Name(s)

BYL719

Intervention Description

300 mg orally once per day (QD)

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

alpelisib matching placebo

Intervention Description

300 mg orally once per day (QD)

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel

Other Intervention Name(s)

abraxane

Intervention Description

100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) Per Investigator Assessment in Study Part A

Description

Time Frame

Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months

Title

Progression-free Survival (PFS) Per Investigator Assessment in Study Part B2

Description

Time Frame

Once approximately 192 PFS events in Study Part B2 had been observed, up to 22 months

Title

Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in Study Part B1

Description

ORR is defined as the proportion of subjects with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS) in Study Part A

Description

OS is defined as the time from date of randomization to date of death due to any cause

Time Frame

Up to 66 months

Title

Overall Survival (OS) in Study Part B2

Description

OS is defined as the time from date of randomization to date of death due to any cause

Time Frame

Up to 41 months

Title

Overall response rate (ORR) with confirmed response in Study Part A

Description

ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1

Time Frame

Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months

Title

Overall response rate (ORR) with confirmed response in Study Part B2

Description

ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1

Time Frame

Up to 22 months

Title

Clinical benefit rate (CBR) with confirmed response in Study Part A

Description

Time Frame

Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months

Title

Clinical benefit rate (CBR) with confirmed response in Study Part B1

Description

Time Frame

Up to 6 months

Title

Clinical benefit rate (CBR) with confirmed response in Study Part B2

Description

Time Frame

Up to 22 months

Title

Time to response (TTR) in Study Part A

Description

Time Frame

Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months

Title

Time to response (TTR) in Study Part B1

Description

Time Frame

Up to 6 months

Title

Time to response (TTR) in Study Part B2

Description

Time Frame

Up to 22 months

Title

Duration of Response (DOR) with confirmed response in Study Part A

Description

Time Frame

Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months

Title

Duration of Response (DOR) with confirmed response in Study Part B1

Description

Time Frame

Up to 6 months

Title

Duration of Response (DOR) with confirmed response in Study Part B2

Description

Time Frame

Up to 22 months

Title

Overall Survival (OS) in Study Part B1

Description

OS is defined as the time from date of enrolment to date of death due to any cause

Time Frame

Up to 6 months

Title

Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1

Description

Time Frame

Up to 6 months

Title

Plasma concentrations of alpelisib in Study Part B2

Description

Summary statistics of plasma alpelisib concentrations by time point

Time Frame

up to 22 months

Title

Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in Study Part B2

Description

Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment

Time Frame

Up to 22 months

Title

Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in Study Part B2

Description

Time Frame

Up to 22 months

Title

PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in Study Part A

Description

PFS in patients with PIK3CA mutation as measured in ctDNA

Time Frame

Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months

Title

PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in Study Part B2

Description

PFS in patients with PIK3CA mutation as measured in ctDNA

Time Frame

Up to 22 months

Title

Time to definitive deterioration of the ECOG performance status from baseline in Study Part B2

Description

Time Frame

Up to 22 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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 Other protocol-defined inclusion/exclusion criteria apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

University Of California Los Angeles Santa Monica Location

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Hematology and Oncology Clinic SC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Mayo Clinic Rochester Mayo - Roch.

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Park Nicollet Institute Dept Onc

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Tennessee Oncology Tennessee Oncology (3)

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1125ABD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Leoben

ZIP/Postal Code

A 8700

Country

Austria

Facility Name

Novartis Investigative Site

City

Barretos

State/Province

ZIP/Postal Code

14784 400

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

01317-002

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230001

Country

China

Facility Name

Novartis Investigative Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050011

Country

China

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330009

Country

China

Facility Name

Novartis Investigative Site

City

Chang Chun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Novartis Investigative Site

City

Shengyang

State/Province

Liaoning

ZIP/Postal Code

110042

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300480

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310016

Country

China

Facility Name

Novartis Investigative Site

City

Dalian

ZIP/Postal Code

116000

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

ZIP/Postal Code

110001

Country

China

Facility Name

Novartis Investigative Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Saint-Cloud

State/Province

Hauts De Seine

ZIP/Postal Code

92210

Country

France

Facility Name

Novartis Investigative Site

City

Angers Cedex 02

ZIP/Postal Code

49055

Country

France

Facility Name

Novartis Investigative Site

City

Saint-Herblain Cédex

ZIP/Postal Code

44805

Country

France

Facility Name

Novartis Investigative Site

City

Villejuif

ZIP/Postal Code

94800

Country

France

Facility Name

Novartis Investigative Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Novartis Investigative Site

City

Faridabad

State/Province

Haryana

ZIP/Postal Code

121 001

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400056

Country

India

Facility Name

Novartis Investigative Site

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632 004

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500034

Country

India

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Meldola

State/Province

ZIP/Postal Code

47014

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00128

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Petaling Jaya

State/Province

Selangor

ZIP/Postal Code

46050

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

NO 0450

Country

Norway

Facility Name

Novartis Investigative Site

City

Trujillo

State/Province

La Libertad

ZIP/Postal Code

13011

Country

Peru

Facility Name

Novartis Investigative Site

City

Gdynia

ZIP/Postal Code

81 519

Country

Poland

Facility Name

Novartis Investigative Site

City

Opole

ZIP/Postal Code

45-061

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

61 485

Country

Poland

Facility Name

Novartis Investigative Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123056

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Pushkin Saint Petersburg

ZIP/Postal Code

196603

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

83310

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

812 50

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

041 91

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Port Elizabeth

State/Province

Western Cape

ZIP/Postal Code

6045

Country

South Africa

Facility Name

Novartis Investigative Site

City

Johannesburg

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Badajoz

State/Province

Extremadura

ZIP/Postal Code

06080

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07120

Country

Spain

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Talas / Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Novartis Investigative Site

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Learn more about this trial

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

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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 (EPIK-B3)

Triple Negative Breast Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial