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Clinical Trials List

Protocol NumberCBYL719H12301
NCT Number(ClinicalTrials.gov Identfier)NCT04251533
Active

2020-03-10 - 2025-07-31

Phase III

Not yet recruiting2

Recruiting3

Terminated1

ICD-10C50.011

Malignant neoplasm of nipple and areola, right female breast

ICD-10C50.012

Malignant neoplasm of nipple and areola, left female breast

ICD-10C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shin-Cheh Chen 無
Taoyuan Chang Gung Memorial Hospital of The C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Liang-Chih Liu Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉建廷 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator YEN-SHEN LU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Triple Negative Breast Neoplasms

Objectives

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

Test Drug

BYL719

Active Ingredient

alpelisib
alpelisib

Dosage Form

Film-coated-tablet

Dosage

50
200

Endpoints

Primary Outcome Measures :
Progression-free Survival (PFS) Per Investigator Assessment in Study part A [ Time Frame: Once approximately 192 PFS events in Study Part A had been observed, up to 35 months ]
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 [ Time Frame: Once approximately 192 PFS events in Study Part B2 had been observed, up to 22 months ]
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

Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in study Part B1 [ Time Frame: Up to 6 months ]
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 [ Time Frame: Up to 66 months ]
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 [ Time Frame: Up to 41 months ]
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 [ Time Frame: Up to 35 months ]
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 [ Time Frame: Up to 22 months ]
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 [ Time Frame: Up to 35 months ]
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 [ Time Frame: Up to 6 months ]
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 B2 [ Time Frame: Up to 22 months ]
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

Time to response (TTR) in Study Part A [ Time Frame: Up to 35 months ]
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 Frame: Up to 6 months ]
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 B2 [ Time Frame: Up to 22 months ]
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

Duration of Response (DOR) with confirmed response in Study Part A [ Time Frame: Up to 35 months ]
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 [ Time Frame: Up to 6 months ]
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 B2 [ Time Frame: Up to 22 months ]
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

Overall Survival (OS) in Study Part B1 [ Time Frame: Up to 6 months ]
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 [ Time Frame: Up to 6 months ]
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 - Part A [ Time Frame: Up to 35 months ]
Summary statistics of plasma alpelisib concentrations by time point in study Part A

Plasma concentrations of alpelisib - Part B1 [ Time Frame: Up to 6 months ]
Summary statistics of plasma alpelisib concentrations by time point in study Part B1

Plasma concentrations of alpelisib -Part B2 [ Time Frame: up to 22 months ]
Summary statistics of plasma alpelisib concentrations by time point in study Part B2

Plasma concentrations of paclitaxel - Part A [ Time Frame: Up to 35 months ]
Summary statistics of plasma paclitaxel concentrations by time point in study Part A

Plasma concentrations of paclitaxel - Part B1 [ Time Frame: up to 6 months ]
Summary statistics of plasma paclitaxel concentrations by time point in study Part B1

Change from baseline in the global health status/Quality of life (QoL) scale score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) in study Part A [ Time Frame: Up to 35 months ]
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

Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in study Part B2 [ Time Frame: Up to 22 months ]
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 A [ Time Frame: Up to 35 months ]
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

Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in study Part B2 [ Time Frame: Up to 22 months ]
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 [ Time Frame: Up to 35 months ]
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 [ Time Frame: Up to 22 months ]
PFS in patients with PIK3CA mutation as measured in ctDNA

Time to definitive deterioration of the Eastern Cooperative Oncology Group (ECOG) performance status (PS) from baseline in Study Part A [ Time Frame: Up to 35 months ]
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

Time to definitive deterioration of the ECOG performance status from baseline in Study Part B2 [ Time Frame: Up to 22 months ]
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

Inclution Criteria

Inclusion Criteria:

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

Exclusion Criteria

Exclusion Criteria:

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

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    566 participants

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