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ACTIVE NOT RECRUITING

NCT05306340

PHASE3

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

Summary

This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.

Official title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

373

Start Date

2022-08-03

Completion Date

2026-10-15

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer

Interventions

DRUG

Giredestrant

Participants will receive treatment with giredestrant 30 milligrams (mg) orally once a day (QD) on Days 1-28 of each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

DRUG

Exemestane

If exemestane is chosen as the physician's choice of endocrine therapy, the participant will receive exemestane at a dose of 25 mg orally once a day (QD) on Days 1-28 of each 28-day cycle or as per local label, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.

DRUG

Fulvestrant

If fulvestrant is chosen as the physician's choice of endocrine therapy, the participant will receive fulvestrant in the clinic at a dose of 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, then Day 1 of each cycle thereafter (1 cycle is 28 days) or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.

DRUG

Tamoxifen

If tamoxifen is chosen as the physician's choice of endocrine therapy, the participant will receive tamoxifen at a dose of 20 mg orally QD on Days 1-28 of each 28-day cycle or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.

DRUG

Everolimus

Participants will receive treatment with everolimus 10 mg orally QD during each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

DRUG

LHRH Agonist

Only premenopausal/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

DRUG

Dexamethasone Mouth Rinse

A compounded alcohol-free mouthwash of dexamethasone (0.5 mg in 5 mL) will be supplied, where feasible. It is strongly recommended for prophylaxis or treatment of stomatitis/mucositis. Participants should use the alcohol-free mouthwash of dexamethasone four times QD for 8 weeks started concurrently with study treatment, and use it reactively thereafter with the first appearance of symptoms.

Inclusion Criteria: 1. Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent 2. Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally 3. Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) Estrogen Receptor 1 (ESR1) mutation status determination by central testing 4. Prior endocrine therapy (ET) in combination with cyclin-dependent kinase 4/6 inhibitors in either setting as follows: * Metastatic setting: Disease progression after ≥6 months on ET plus CDK4/6 inhibitor in the locally advanced or metastatic setting. If ET plus CDK4/6 inhibitor is not the most recent therapy, then patient must also have had disease progression after ≥4 months on most recent ET * Adjuvant Setting: Relapse either while taking or within 12 months of exposure to combination adjuvant ET and CDK4/6 inhibitor. Patients must have taken at least 12 months of adjuvant ET, 6 months of which was in combination with a CDK4/6 inhibitor. 5. Measurable disease as defined per RECIST v.1.1 or evaluable bone metastases. Patients with evaluable bone disease in the absence of measurable disease outside of the bone must have at least one predominantly lytic bone lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) which can be followed 6. Eastern Cooperative Oncology Group Performance Status 0-1 7. For women who are premenopausal or perimenopausal and for men: treatment with approved luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of study treatment Exclusion Criteria: 1. Prior treatment with another oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM), or everolimus in any setting. Prior fulvestrant is allowed if treatment was terminated at least 28 days prior to randomization. Prior treatment with tamoxifen is allowed. 2. Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting 3. Prior chemotherapy for locally advanced unresectable or metastatic disease 4. Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization 5. Treatment with any investigational therapy within 28 days prior to initiation of study treatment 6. Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization 7. History of any other malignancy other than breast cancer within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer, or other non-breast cancers at very low risk of recurrence 8. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term 9. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease 10. Active cardiac disease or history of cardiac dysfunction 11. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C including active viral or other hepatitis virus, current alcohol abuse, or cirrhosis 12. Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection 13. Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy 14. Serious infection requiring oral or intravenous (IV) antibiotics, or other clinically significant infection, within 14 days prior to randomization 15. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study 16. Known allergy or hypersensitivity to any of the study drugs or any of their excipients 17. For premenopausal or perimenopausal women and for men: known hypersensitivity to LHRH agonists 18. Pregnant or breastfeeding

Locations (136)

Alaska Oncology & Hematology, LLC

Anchorage, Alaska, United States

Arizona Oncology Associates, PC-CASA

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Alta Bates Summit Medical Center

Berkeley, California, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

TOI Clinical Research

Cerritos, California, United States

Women's Cancer Care

Fresno, California, United States

Scripps Health

La Jolla, California, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

University of California, Irvine Medical Center

Orange, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

Summit Cancer Care PC

Savannah, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Eastern Maine Medical Center

Brewer, Maine, United States

New England Cancer Specialists

Scarborough, Maine, United States

Anne Arundel Health System Research Institute

Annapolis, Maryland, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Mercy Medical Center

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Renown Regional Medical Center

Reno, Nevada, United States

Memorial Sloan Kettering - Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering - Monmouth

Middletown, New Jersey, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

The Blavatnik Family ? Chelsea Medical Center at Mount Sinai

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

SCRI Mark H. Zangmeister Center

Columbus, Ohio, United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, United States

St Charles Medical Center Bend

Bend, Oregon, United States

Abramson Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center - Magee-Women?s Hospital

Pittsburgh, Pennsylvania, United States

Abramson Cancer Center Chester County Hospital

West Chester, Pennsylvania, United States

McGlinn Cancer Institute at Reading Hospital

West Reading, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

West Cancer Center

Germantown, Tennessee, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Bedford, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology-Denton South

Denton, Texas, United States

Texas Oncology, P.A. - El Paso

El Paso, Texas, United States

Houston Methodist Cancer Center

Houston, Texas, United States

Millennium Research & Clinical Development

Houston, Texas, United States

Texas Oncology P.A.

San Antonio, Texas, United States

Inova Fairfax Hospital

Fairfax, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Instituto de Oncología Ángel H. Roffo

Agronomía, Ciudad Autónoma de BuenosAires, Argentina

Fundación CENIT para la Investigación en Neurociencias

Recoleta, Ciudad Autónoma de BuenosAires, Argentina

Consultorios Médicos Dr. Doreski

Ciudad Autonoma Buenos Aires, Argentina

Centro Medico Privado CEMAIC

Córdoba, Argentina

Fundacion Centro Oncologico de Integracion Regional (COIR)

Mendoza, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Instituto de Oncologia de Rosario

Rosario, Argentina

Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

San Juan, Argentina

Organizacion Medica de Investigacion

San Nicolás, Argentina

Centro de Investigación Clínica ? Clínica Viedma

Viedma, Argentina

Knappschaft Kliniken Marienhospital Bottrop

Bottrop, Germany

Universitatsklinikum Erlangen

Erlangen, Germany

Kliniken Essen-Mitte

Essen, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Germany

University of Athens, Hematological Clinic,

Athens, Greece

Attikon University General Hospital

Athens, Greece

Metropolitan General Hospital

Cholargós, Greece

University General Hospital of Heraklion

Heraklio, Greece

University General Hospital of Larissa

Larissa, Greece

IASO Obstetrics Gynecology Clinic

Marousi, Greece

Agios Loucas Clinic SA

Panórama, Greece

Olympion Clinic

Pátrai, Greece

Metaxa Cancer Hospital of Piraeus

Piraeus, Greece

Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

Azienda Ospedaliero - Universitaria di Modena Policlinico

Modena, Emilia-Romagna, Italy

Istituto Nazionale Tumori Regina Elena IRCCS

Rome, Lazio, Italy

Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Asst Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette Di Ancona, The Marches, Italy

"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

Verona, Veneto, Italy

Aichi Cancer Center

Aichi, Japan

Nagoya University Hospital

Aichi, Japan

Chiba Cancer Center

Chiba, Japan

National Cancer Center Hospital East

Chiba, Japan

Shikoku Cancer Center

Ehime, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Japan

Hokkaido University Hospital

Hokkaido, Japan

Hyogo Cancer Center

Hyōgo, Japan

University of Tsukuba Hospital

Ibaraki, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Tokai University Hospital

Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Japan

Niigata Cancer Center Hospital

Niigata, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Juntendo University Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

National University Hospital

Singapore, Singapore

Oncocare Cancer Centre

Singapore, Singapore

Medical Oncology Centre of Rosebank

Johannesburg, South Africa

Chungbuk National University Hospital

Cheongju-si, South Korea

Soon Chun Hyang University Cheonan Hospital

Dongnam-gu, Cheonan-si, South Korea

National Cancer Center

Goyang-si, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

A Coruña, LA Coruna, Spain

Hospital Dexeus

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital General Universitario J.M Morales Meseguer

Murcia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Changhua Christian Hospital

Chang-hua, Taiwan

Chang Gung Memorial Hospital

Kaohsiung Country, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou Branch

Taipei, Taiwan

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

SAKARYA University Medical Faculty

Sakarya, Turkey (Türkiye)

Dorset County Hospital

Dorchester, United Kingdom

North Middlesex Uni Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Clinical Research Directory

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (136)