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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)

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Alpelisib

Fulvestrant

Alpelisib-matching placebo

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Alpelisib, Fulvestrant, Advanced breast cancer, Phase III, HR-positive, HER-2 negative, CDK4/6 inhibitor, PIK3CA mutation, Progression free survival, aromatase inhibitor

Eligibility Criteria

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

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alpelisib plus fulvestrant

Alpelisib-matching placebo plus fulvestrant

Arm Description

Alpelisib 300 mg orally once daily on a continuous dosing schedule, in a 28-day cycle + fulvestrant 500 mg as intramuscular injection on Cycle 1 Day 1 and 15, and on Day 1 on every Cycle thereafter, in a 28 days cycle.

Alpelisib-matching placebo orally once daily on a continuous dosing schedule, in a 28-day cycle + fulvestrant 500 mg as intramuscular injection on Cycle 1 Day 1 and 15 and on Day 1 on every Cycle thereafter, in a 28 days cycle. Participants who have disease progression per RECIST v1.1 as assessed by BIRC will have the option to crossover to be treated with alpelisib plus fulvestrant

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) based on BIRC assessments and using RECIST v1.1 criteria

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to treatment with placebo plus fulvestrant. PFS is the defined as the time from randomization to date of randomization to the date of the first documented progression as per BIRC criteria using RECIST v1.1 or death due to any cause, whichever comes first.

Secondary Outcome Measures

Overall survival (OS)

To determine whether treatment with alpelisib plus fulvestrant prolongs overall survival (OS) compared to treatment with placebo plus fulvestrant. OS is defined as the time from randomization to the date of death due to any cause

Overall response rate (ORR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

To evaluate alpelisib plus fulvestrant compared to placebo plus fulvestrant, with regards to objective response by RECIST 1.1 criteria. Overall response rate (ORR) with confirmed response is defined as the proportion of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as per BIRC and according to RECIST 1.1

Clinical benefit rate (CBR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

To evaluate alpelisib plus fulvestrant compared to placebo plus fulvestrant, with regards to objective response by RECIST 1.1 criteria. CBR with confirmed response is defined as the proportion of participants with a best overall response of confirmed CR or PR, or SD lasting for a duration of at least 24 weeks. CR, PR and SD are defined as per BIRC review according to RECIST 1.1

Duration of response (DOR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

To evaluate alpelisib plus fulvestrant compared to placebo plus fulvestrant, with regards to objective response by RECIST 1.1 criteria. Duration of response (DOR) with confirmed response only applies to participants 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 BIRC review. The start date is the date of first documented response of CR or PR and the end date is defined as the date of the first documented progression or death due to underlying cancer.

Time to response (TTR) based on BIRC assessments and using RECIST v1.1 criteria

To evaluate alpelisib plus fulvestrant compared to placebo plus fulvestrant, with regards to objective response by RECIST 1.1 criteria. Time to response (TTR) is defined as the time from the date of randomization to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed. CR and PR are based on tumor response data as per BIRC review and according to RECIST 1.1

PFS based on BIRC assessment and using RECIST v1.1 criteria for participants by PIK3CA mutation status

To evaluate the association between PIK3CA mutation status with PFS upon treatment with alpelisib. PFS is the defined as the time from randomization to date of randomization to the date of the first documented progression as per BIRC criteria using RECIST v1.1 or death due to any cause, whichever comes first. Results will be presented by PIK3CA mutation status measured in circulating tumor deoxyribonucleic acid (ctDNA) collected at baseline.

Time to definitive deterioration of Eastern Cooperative Oncology Group (ECOG) performance status (PS) from baseline

To evaluate treatment with alpelisib plus fulvestrant compared to placebo plus fulvestrant, with respect to time to deterioration of ECOG performance status. Time to definitive deterioration in ECOG PS is defined as the time from the date of randomization to the date when ECOG PS has definitively deteriorated by at least one category compared with baseline. Deterioration is considered definitive if there is no subsequent improvement in ECOG PS back to the baseline category or above.

Time to definitive (10%) deterioration in the global health status/Quality of Life (QoL) and symptom scale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)

To evaluate patient-reported outcomes of alpelisib plus fulvestrant compared to placebo and fulvestrant. 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 and symptom scale scores of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items and is composed of both multi-item scales and single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items and a global health status/QoL scale. The scales and single-item measures range in score from 0 - 100. A high scale score represents a higher response level.

Change from baseline in global health status/QoL and symptom scale scores of the EORTC QLQ-C30

To evaluate patient-reported outcomes of alpelisib plus fulvestrant compared to placebo and fulvestrant. Change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment. EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items and is composed of both multi-item scales and single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items and a global health status/QoL scale. The scales and single-item measures range in score from 0 - 100. A high scale score represents a higher response level.

Time from randomization to objective tumour progression on next line treatment or death from any cause (PFS2)

To explore the long-term benefit intermediate to PFS and OS. PFS2 is defined as time from date of randomization to the first documented progression on nextline therapy or death from any cause, whichever occurs first. Disease progression will be determined based on investigator assessment of progression on next-line therapy.

Full Information

NCT ID

NCT05038735

First Posted

September 1, 2021

Last Updated

September 6, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05038735

Brief Title

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.

Acronym

EPIK-B5

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 29, 2021 (Actual)

Primary Completion Date

August 31, 2026 (Anticipated)

Study Completion Date

September 23, 2026 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

This is a Phase III, randomized, double-blind, placebo-controlled, international, multi-center trial. Approximately 234 men and postmenopausal women will be randomized to either alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant. Randomization will follow a 1:1 randomization ratio and be stratified by presence of lung and/or liver metastases (yes vs. no) and setting at last prior CDK4/6 inhibitor therapy (adjuvant vs metastatic). Study treatment with alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant will be initiated on Cycle 1 Day 1, and will continue until disease progression per RECIST v1.1 as per BIRC assessment, start of new antineoplastic therapy, death, lost to follow-up, or withdrawal of consent. A cycle is defined as 28 days. Participants randomized to the alpelisib-matching placebo plus fulvestrant arm who have disease progression per RECIST v1.1 as assessed by BIRC will have the option to crossover to be treated with alpelisib plus fulvestrant. Unblinding a single participant at a site will be permitted after disease progression confirmed by BIRC after discussion with the Novartis team to determine eligibility for cross-over to treatment with alpelisib plus fulvestrant.

6. Conditions and Keywords

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

Breast Cancer

Keywords

Alpelisib, Fulvestrant, Advanced breast cancer, Phase III, HR-positive, HER-2 negative, CDK4/6 inhibitor, PIK3CA mutation, Progression free survival, aromatase inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alpelisib plus fulvestrant

Arm Type

Experimental

Arm Description

Arm Title

Alpelisib-matching placebo plus fulvestrant

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Alpelisib

Intervention Description

Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.

Intervention Type

Drug

Intervention Name(s)

Fulvestrant

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Alpelisib-matching placebo

Intervention Description

Alpelisib-matching placebo (tablets) administered orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.

Primary Outcome Measure Information:

Title

Progression-free survival (PFS) based on BIRC assessments and using RECIST v1.1 criteria

Description

Time Frame

From randomization to date of the first documented progression or death due to any cause, assessed up to a maximum duration of 60 months.

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

Time Frame

From the date of randomization to the date of death up to a maximum duration of 60 months

Title

Overall response rate (ORR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

Description

Time Frame

From the date of randomization up to a maximum duration of 60 months

Title

Clinical benefit rate (CBR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

Description

Time Frame

From the date of randomization up to a maximum duration of 60 months

Title

Duration of response (DOR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

Description

Time Frame

From first documented response to the date of first progression or deaths, up to a maximum duration of 60 months

Title

Time to response (TTR) based on BIRC assessments and using RECIST v1.1 criteria

Description

Time Frame

From the date of randomization to the first documented response up to a maximum duration of 60 months

Title

PFS based on BIRC assessment and using RECIST v1.1 criteria for participants by PIK3CA mutation status

Description

Time Frame

From the date of randomization up to a maximum duration of 60 months

Title

Time to definitive deterioration of Eastern Cooperative Oncology Group (ECOG) performance status (PS) from baseline

Description

Time Frame

From the date of randomization up to maximum duration of 60 months

Title

Description

Time Frame

From the date of randomization up to maximum duration of 60 months

Title

Change from baseline in global health status/QoL and symptom scale scores of the EORTC QLQ-C30

Description

Time Frame

From the date of randomization up to maximum duration of 60 months

Title

Time from randomization to objective tumour progression on next line treatment or death from any cause (PFS2)

Description

Time Frame

From the date of randomization up to maximum duration of 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Investigator (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 ≤2 prior lines of systemic therapies overall in the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy). Participant must show the presence of a PIK3CA mutation(s) determined in tumor tissue prior ro enrollment either by a Novartis designated laboratory or in tumor tissue or plasma ctDNA by a local laboratory using a Food and Drug Administration (FDA)-approved PIK3CA Companion Diagnostics (CDx) test for alpelisib or the CE-IVD QIAGEN Therascreen® PIK3CA RGQ PCR test. 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/endocrine-based therapy with no treatment for metastatic disease Participant has received prior treatment with fulvestrant, any oral selective estrogen receptor degrader (SERDs), any Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor Other Inclusion and Exclusion Criteria do apply

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

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

Novartis Investigative Site

City

Sint Niklaas

State/Province

Oost Vlaanderen

ZIP/Postal Code

9100

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1303

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1750

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9002

Country

Bulgaria

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Novy Jicin

State/Province

Czech Republic

ZIP/Postal Code

74101

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

65653

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Praha 4

ZIP/Postal Code

140 59

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK 9000

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Odense C

ZIP/Postal Code

DK 5000

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

FIN-33521

Country

Finland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Besancon Cedex

ZIP/Postal Code

25030

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Clermont Ferrand

ZIP/Postal Code

63011

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

La Roche sur Yon Cedex

ZIP/Postal Code

85925

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lyon

ZIP/Postal Code

69373

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34298

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Paris 10

ZIP/Postal Code

75475

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75970

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Valenciennes

ZIP/Postal Code

59300

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Villejuif

ZIP/Postal Code

94800

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ravensburg

ZIP/Postal Code

88214

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

54645

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

15123

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

GR 115 22

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H 1122

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Dublin 9

State/Province

ZIP/Postal Code

D09

Country

Ireland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Dublin 4

ZIP/Postal Code

D04 T6F

Country

Ireland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Dublin 8

ZIP/Postal Code

D08

Country

Ireland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Brindisi

State/Province

ZIP/Postal Code

72100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20141

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Aviano

State/Province

ZIP/Postal Code

33081

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00155

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Terni

State/Province

ZIP/Postal Code

05100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85 796

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 952

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Opole

ZIP/Postal Code

45 054

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1099 023

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1400-038

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1500 650

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1649-019

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Floresti

State/Province

Cluj

ZIP/Postal Code

407280

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200347

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Constanta

ZIP/Postal Code

905900

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Timisoara

ZIP/Postal Code

300425

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

83310

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

812 50

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04191

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29011

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Jerez

State/Province

Cadiz

ZIP/Postal Code

11407

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lerida

State/Province

Cataluna

ZIP/Postal Code

25198

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Badajoz

State/Province

Extremadura

ZIP/Postal Code

06080

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

A Coruna

State/Province

Galicia

ZIP/Postal Code

15009

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Individual Site Status

Recruiting

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

Learn more about this trial

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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)

Breast Cancer

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