Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor

ClinicalTrials.gov Identifier: NCT05038735

Novartis Reference Number: CBYL719C2303

Last Update: Sep 07, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

Condition 
Breast Cancer
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Nov 29, 2021
Completion date 
Sep 23, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Alpelisib
Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.
Drug
Fulvestrant
Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle (each cycle is 28 days).
Drug
Alpelisib-matching placebo
Alpelisib-matching placebo (tablets) administered orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.

Eligibility Criteria

Inclusion Criteria:

Participant is an adult ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines.
If female, then the participant must be in postmenopausal status. Postmenopausal status is defined either by: prior bilateral oophorectomy, age ≥60 or age <60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range per local normal range.
Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
Participant has at least one measurable lesion as per RECIST v1.1 criteria as assessed by BIRC (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).
Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4/6 inhibitor therapy. The combined AI and CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting).
Participant has received ≤1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy).
Participant must show the presence of a PIK3CA mutation(s) determined by tissue either by a local laboratory using only CE-marked IVD assays such as QIAGEN Therascreen® PIK3CA RGQ PCR test or by a Novartis designated laboratory.

Exclusion Criteria:

Participant with symptomatic visceral disease that makes the participant ineligible for endocrine therapy (ET) per the investigator's best judgment.
Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
Participant has received prior treatment with fulvestrant, any Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor

Other Inclusion and Exclusion Criteria do apply

Study Locations

Belgium
Novartis Investigative Site
Recruiting
Sint Niklaas, 9100
Vlaams Brabant
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1200
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Belgium
Novartis Investigative Site
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Leuven, 3000
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Belgium
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Liege, 4000
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Belgium
Bulgaria
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Recruiting
Burgas, 8000
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Bulgaria
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Plovdiv, 4004
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Bulgaria
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Sofia, 1303
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Bulgaria
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Sofia, 1756
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Bulgaria
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Varna, 9002
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Bulgaria
Canada
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Ottawa, K1H 8L6
Ontario
Canada
Czech Republic
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Recruiting
Novy Jicin, 74101
Czech Republic
Czech Republic
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Recruiting
Brno, 65653
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Czech Republic
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Recruiting
Praha 10, 100 34
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Czech Republic
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Praha 4, 140 59
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Czech Republic
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Praha, 12808
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Czech Republic
Denmark
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Aalborg, DK 9000
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Denmark
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Copenhagen, DK-2100
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Denmark
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Odense C, DK 5000
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Denmark
Finland
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Helsinki, 00029
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Finland
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Tampere, FIN-33521
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Finland
France
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Besancon Cedex, 25030
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France
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Clermont Ferrand, 63011
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France
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La Roche sur Yon Cedex, 85925
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France
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Lyon Cedex, 69373
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France
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Marseille, 13273
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France
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Montpellier Cedex 5, 34298
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France
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Paris Cedex 10, 75475
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France
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Paris, 75970
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France
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Valenciennes, 59300
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France
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Villejuif Cedex, 94800
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France
Germany
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Augsburg, 86150
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Germany
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Berlin, 10117
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Germany
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Essen, 45136
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Germany
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Koeln, 50937
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Germany
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Luebeck, 23538
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Germany
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Muenchen, 81377
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Germany
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Ravensburg, 88214
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Germany
Greece
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Athens, 15123
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Greece
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Athens, GR 115 22
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Greece
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Patras, 265 00
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Greece
Hungary
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Budapest, H 1122
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Hungary
Ireland
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Dublin 9,
D9
Ireland
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Dublin 4, D04 T6F
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Ireland
Italy
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Bergamo, 24127
BG
Italy
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Bologna, 40138
BO
Italy
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Brindisi, 72100
BR
Italy
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Firenze, 50134
FI
Italy
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Genova, 16132
GE
Italy
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Milano, 20132
MI
Italy
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Milano, 20133
MI
Italy
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Milano, 20141
MI
Italy
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Rozzano, 20089
MI
Italy
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Palermo, 90127
PA
Italy
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Roma, 00168
RM
Italy
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Terni, 05100
TR
Italy
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Napoli, 80131
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Italy
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Novara, 28100
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Italy
Poland
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Bydgoszcz, 85 796
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Poland
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Gdansk, 80 952
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Poland
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Opole, 45 054
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Poland
Portugal
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Coimbra, 3000-075
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Portugal
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Lisboa, 1400-038
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Portugal
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Lisboa, 1500 650
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Portugal
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Lisboa, 1649-019
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Portugal
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Porto, 4200-072
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Portugal
Slovakia
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Bratislava, 83310
Slovak Republic
Slovakia
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Bratislava, 812 50
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Slovakia
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Kosice, 04191
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Slovakia
Spain
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Malaga, 29011
Andalucia
Spain
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Oviedo, 33011
Asturias
Spain
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Jerez, 11407
Cadiz
Spain
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Barcelona, 08036
Catalunya
Spain
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Badajoz, 06080
Extremadura
Spain
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Pozuelo de Alarcon, 28223
Madrid
Spain
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Madrid, 28040
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Spain

Contacts

Name: 
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Phone: 

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