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Trial details
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
Current status:
Approved
|
Date registered:
29/06/2022
Trial version(s)
History: 04/11/2021
History: 04/11/2021
History: 04/11/2021
History: 04/11/2021
History: 04/11/2021
History: 04/11/2021
Current: 04/11/2021
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022054889
Protocol number
CBYL719G12301
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
Acronym
Scientific title
EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
Acronym
EPIK-B2
Brief summary of the study: English
The purpose of this two parts multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.
Brief summary of the study: Arabic
هدف هذه الدراسة هو معرفة ما إذا كان دواء ألبيليسيب عندما يُضاف إلى تراستوزوماب وبرتوزوماب يساعد على الحدّ من نموّ خلايا سرطان الثدي لدى المرضى المصابين بسرطان الثدي المتقدّم إيجابي البروتين "هير 2" HER2.
Health conditions/problem studied: Specify
Advanced HER2+Breast Cancer
Interventions: Specify
Drug: Alpelisib Alpelisib - continuous once daily, in a 21-day cycle Other Name: BYL719 Drug: Alpelisib matching Placebo Alpelisib matching placebo: continuous once daily, in a 21-day cycle Drug: Trastuzumab Trastuzumab - Day 1 of Cycle 1, and on Day 1 (+/- 3 days) of every cycle thereafter Drug: Pertuzumab Pertuzumab - Day 1 of Cycle 1, and on Day 1 (+/- 3 days) of every cycle thereafter
Key inclusion and exclusion criteria: Inclusion criteria
- Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic). - Participant has received pre-study induction therapy with up to and including a maximum of 6 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. 4 or 5 cycles of induction therapy are permitted if discontinuation of taxane was due to taxane toxicity. - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Participant has adequate bone marrow and organ function - Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion Criteria: - Participant with inflammatory breast cancer at screening. - Participant with evidence of disease progression during the pre-study induction therapy and prior to first dose of alpelisib (or alpelisib/alpelisib matching-placebo for Part 2) - Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c. - Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis - Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events - Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN). - Participant has currently documented pneumonitis/interstitial lung disease
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Other
Study design: Specify assignment
sequential
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
USA, Europe
Name of IMP
Alpelisib
Year of authorization
2019
Month of authorization
5
Type of IMP
Gene therapy
Pharmaceutical class
phosphatidylinositol 3-kinase (PI3K) inhibitor
Therapeutic indication
Patients with HER2-positive Advanced Breast Cancer with a PIK3CA Mutation
Therapeutic benefit
Progression Free Survival
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples will be shipped to Q2 solutions lab
Target sample size
4
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/08/2022
Date of study closure: Type
Anticipated
Date of study closure: Date
29/09/2031
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com. https://www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT04208178?term=CBYL719G12301&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical trials.gov
NCT04208178
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Fadi
Farhat
Saida
Lebanon
+961 3 753155
drfadi.trials@gm ail.com
Hammoud Hospital University Medical Center
Scientific
Hind
Khairallah
Beirut
Lebanon
+961 1 512002 Ext. 271
hind.khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l
Public
Marwan
Ghosn
Beirut
Lebanon
+961 3 226842
marwan.ghosn@usj.edu.lb
Hotel Dieu de France Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Fadi Farhat
Hematology Oncology
Approved
Hotel Dieu de France
Marwan Ghosn
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
30/06/2021
Ibrahim Omeis
iomeis@hammoudhospital.org
+961 (0) 7 723111 ext 1222/1223
Hotel Dieu de France
29/09/2021
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Countries of Recruitment
Name
Belgium
China
France
Spain
United States of America
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Advanced HER2+Breast Cancer
Malignant neoplasm of breast (C50)
Advanced HER2+Breast Cancer
Interventions
Intervention
Description
Keyword
IMP administration , ICF, visit assessment and schedule
IMP administration , ICF, visit assessment and schedule
IMP administration , ICF, visit assessment and schedule
Primary Outcomes
Name
Time points
Measure
Part 1
6 weeks
Incidence of dose limiting toxicities (DLTs) for each dose level
Part 2
Up to approximately 38 months
Progression Free Survival (PFS)
Key Secondary Outcomes
Name
Time points
Measure
Part 1
Day 8 of Cycle 1 and then Day 1 of Cycle 2, Cycle 4, Cycle 6 and Cycle 10 (Each cycle = 21 days)
Summary statistics of alpelisib concentrations by timepoint and dose level
Part 2
Up to approximately 70 months
Overall survival (OS)
Part 2
Day 8 of Cycle 1 and then Day 1 of Cycle 2, Cycle 4, Cycle 6 and Cycle 10 (Each cycle = 21 days)
Summary statistics of alpelisib concentrations by timepoint and dose level
Part 2
Up to approximately 38 months
Overall response rate (ORR) with confirmed response
Part 2
Up to approximately 38 months
Clinical Benefit Rate (CBR) with confirmed response
Part 2
Up to approximately 38 months
Time to response (TTR) based on local radiology assessments
Part 2
Up to approximately 38 months
Duration of response (DOR) with confirmed response
Part 2
Baseline, approximately 38 months
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) treatment outcomes index (TOI) from baseline
Part 2
Up to approximately 38 months
Time to deterioration in FACT-B TOI (defined as a ≥ 5 point decrease from baseline)
Part 2
Up to approximately 38 months
PFS based on local radiology assessments
Part 2
Baseline, up to approximately 38 months
Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Adding site HDF
08/06/2022
PA02_HHUMC_IRB Approval
08/06/2022
Download as PDF
Save a PDF copy of the summary of the trial