Clinical Trials List
Protocol NumberCBYL719G12301
NCT Number(ClinicalTrials.gov Identfier)NCT04208178
2020-02-25 - 2023-01-09
Phase III
Recruiting4
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
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kuo-Ting Lee 無
- Ya-Ping Chen 無
- Yao-Lung Kuo 無
- 楊舜如 無
- Ya-Ting Hsu 無
- Jui-Hung Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張端瑩 無
- 羅喬 無
- MING-YANG WANG 無
- 郭文宏 無
- YEN-SHEN LU 無
- Wei-Wu Chen 無
- 林季宏 無
- 林柏翰 無
- 陳怡君 無
- WEI-LI MA 無
- 張允中 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ta-Chung Chao 無
- 賴亦貞 無
- Chun-Yu Liu 無
- 邱仁輝 無
- 林燕淑 無
- Chi-Cheng Huang 無
- Jiun-I Lai 無
- 馮晉榮 無
- Yi-Fang Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced HER2+Breast Cancer
Objectives
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.
Test Drug
Alpelisib (BYL719)
Active Ingredient
Alpelisib (BYL719)
Dosage Form
film-coated tablet
Dosage
50mg, 200mg
Endpoints
Primary Outcome Measures :
1.Part 1: Incidence of dose limiting toxicities (DLTs) for each dose level.
2.Part 2: Progression Free Survival (PFS).
Secondary Outcome Measures:
1.Part 1:Summary statistics of alpelisib concentrations by timepoint and dose level .
2.Part 2: Overall survival (OS) (Key Secondary) .
3.Part 2: Summary statistics of alpelisib concentrations by timepoint and dose level .
4.Part 2: Overall response rate (ORR) with confirmed response .
5.Part 2: Clinical Benefit Rate (CBR) with confirmed response.
6.Part 2: Time to response (TTR) based on local radiology assessments.
7.Part 2: Duration of response (DOR) with confirmed response.
8.Part 2: Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) treatment outcomes index (TOI) from baseline.
9.Part 2: Time to deterioration in FACT-B TOI (defined as a ≥ 5 point decrease from baseline).
10.Part 2: PFS based on local radiology assessments.
11.Part 2: Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status.
1.Part 1: Incidence of dose limiting toxicities (DLTs) for each dose level.
2.Part 2: Progression Free Survival (PFS).
Secondary Outcome Measures:
1.Part 1:Summary statistics of alpelisib concentrations by timepoint and dose level .
2.Part 2: Overall survival (OS) (Key Secondary) .
3.Part 2: Summary statistics of alpelisib concentrations by timepoint and dose level .
4.Part 2: Overall response rate (ORR) with confirmed response .
5.Part 2: Clinical Benefit Rate (CBR) with confirmed response.
6.Part 2: Time to response (TTR) based on local radiology assessments.
7.Part 2: Duration of response (DOR) with confirmed response.
8.Part 2: Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) treatment outcomes index (TOI) from baseline.
9.Part 2: Time to deterioration in FACT-B TOI (defined as a ≥ 5 point decrease from baseline).
10.Part 2: PFS based on local radiology assessments.
11.Part 2: Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status.
Inclution Criteria
1.Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic).
2.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.
3.Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
4.Participant has adequate bone marrow and organ function.
5.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.
2.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.
3.Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
4.Participant has adequate bone marrow and organ function.
5.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.
Exclusion Criteria
1.Participant with inflammatory breast cancer at screening.
2.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).
3.Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c.
4.Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
5.Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events.
6.Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN).
7.Participant has currently documented pneumonitis/interstitial lung disease.
2.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).
3.Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c.
4.Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
5.Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events.
6.Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN).
7.Participant has currently documented pneumonitis/interstitial lung disease.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
526 participants
