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ACTIVE NOT RECRUITING

NCT04961996

PHASE3

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Official title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4170

Start Date

2021-08-27

Completion Date

2033-09-30

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Early Breast Cancer

Interventions

DRUG

Giredestrant

Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

DRUG

Physician's Choice of Endocrine Therapy

The physician's choice of endocrine therapy (PCET) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive PCET daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing PCET after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of PCET should be performed in accordance with the local prescribing information for the respective product.

DRUG

LHRH Agonist

A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. LHRH agonists may include, but are not limited to, leuprolide acetate, goserelin acetate, or triptorelin pamoate. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Inclusion Criteria: * Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen * Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity * Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection \[ALND\] and/or sentinel lymph node biopsy \[SLNB\]) * Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization. * Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment) * Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery * Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded \[FFPE\] tissue block \[preferred\] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study. * Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2 * Able and willing to swallow, retain, and absorb oral medication * Adequate organ function Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice * Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study * Receiving or planning to receive a CDK4/6 inhibitor as (neo)adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed. * Active cardiac disease or history of cardiac dysfunction * Diagnosed with Stage IV breast cancer * A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible. * A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer * Any prior endocrine treatment with selective ER modulators (e.g., tamoxifen), degraders, or aromatase inhibitors. A short course of neoadjuvant or adjuvant endocrine therapy (up to 12 weeks) is allowed. * Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \[HBV\] or hepatitis C virus \[HCV\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis * Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment * Known allergy or hypersensitivity to any of the study drugs or any of their excipients * Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists * A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism * Renal dysfunction that requires dialysis * A major surgical procedure unrelated to breast cancer within 28 days prior to randomization * A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study * Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

Locations (621)

Southern Cancer Center

Daphne, Alabama, United States

CBCC Global Research Inc., at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

St Joseph Heritage Healthcare

Fullerton, California, United States

Long Beach Memorial Medical Center

Long Beach, California, United States

Cancer and Blood Specialty Clinic-California-Katella Ave

Los Alamitos, California, United States

The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

Orange, California, United States

Kaiser Permanente - San Diego

San Diego, California, United States

Sansum Clinic

Santa Barbara, California, United States

UCLA Hematology/Oncology

Santa Monica, California, United States

Torrance Memorial Physician Network/Cancer Care

Torrance, California, United States

Kaiser Permanente - Vallejo

Vallejo, California, United States

Rocky Mountain Cancer Centers (Longmont) - USOR

Longmont, Colorado, United States

Stamford Hospital

Stamford, Connecticut, United States

Memorial Healthcare System - Memorial Regional Hospital

Hollywood, Florida, United States

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

University of Chicago Hospital

Chicago, Illinois, United States

Duly Health and Care

Tinley Park, Illinois, United States

Cancer Center of Kansas - Kingman

Kingman, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Norton Cancer Institute - MDC

Louisville, Kentucky, United States

Hematology/Oncology Clinic, LLP

Baton Rouge, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

University of Maryland

Towson, Maryland, United States

Lahey Clinic Med Ctr

Burlington, Massachusetts, United States

Massachusetts General Hospital

Lexington, Massachusetts, United States

University Of Michigan

Ann Arbor, Michigan, United States

Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

University of Missouri-Columbia

Columbia, Missouri, United States

St. Vincent Frontier Cancer Center

Billings, Montana, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Hunterdon Hematology Oncology

Flemington, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

New York University Cancer Cen

New York, New York, United States

Stony Brook Univ Cancer Ctr

Stony Brook, New York, United States

Messino Cancer Centers

Asheville, North Carolina, United States

Rex Cancer Center

Raleigh, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center - PPDS

Winston-Salem, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Columbus NCORP

Columbus, Ohio, United States

Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States

Kaiser Permanente-Northwest Region

Portland, Oregon, United States

Pinnacle Health

Harrisburg, Pennsylvania, United States

Penn State Univ. Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Women & Infants Hospital

Providence, Rhode Island, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

West Cancer Center & Research Institute

Germantown, Tennessee, United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology (Grandview) - USOR

El Paso, Texas, United States

Texas Oncology (Flower Mound) - USOR

Flower Mound, Texas, United States

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, United States

Baylor College of Medicine Medical Center

Houston, Texas, United States

Houston Methodist Cancer Center

Houston, Texas, United States

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, United States

Texas Oncology (McAllen) - USOR

McAllen, Texas, United States

USOR - Texas Oncology - San Antonio Northeast

San Antonio, Texas, United States

Texas Oncology (Tyler) - USOR

Tyler, Texas, United States

Texas Oncology (Waco) - USOR

Waco, Texas, United States

Centra Alan B. Pearson Regional Cancer Center

Lynchburg, Virginia, United States

Bon Secours Mercy Health

Midlothian, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

Roanoke, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

West Virginia University Hospitals Inc

Morgantown, West Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Fundacion Intectus

Bariloche, Río Negro Province, Argentina

Hospital Italiano Regional del Sur

Bahía Blanca, Argentina

Instituto de Investigaciones Clinicas-Mar del Plata

Buenos Aires, Argentina

Instituto de Investigaciones Metabólicas (IDIM)

Buenos Aires, Argentina

Centro Oncologico Korben

Caba, Argentina

Fundacion Medica de Rio Negro Y Nuequen

Cipolletti, Argentina

Consultorios Médicos Dr. Doreski

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Allende Servicio Nefrología

Córdoba, Argentina

Centro Medico Privado CEMAIC

Córdoba, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Hospital Privado de La Comunidad

Mar del Plata, Argentina

Centro de Investigacion Pergamino SA

Pergamino, Argentina

Exelsus clinica Oncologica

Provincia de Tucumán, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

Rosario, Argentina

Sanatorio Parque de Rosario

Rosario, Argentina

Instituto de Oncologia de Rosario

Rosario, Argentina

Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

San Juan, Argentina

Centro Médico Privado de Reumatología

San Miguel de Tucumán, Argentina

Organizacion Medica de Investigacion

San Nicolás, Argentina

Fundación Ars Medica

San Salvador de Jujuy, Argentina

Centro de Investigación Clínica ? Clínica Viedma

Viedma, Argentina

Border Medical Oncology Research Unit

Albury, New South Wales, Australia

Campbelltown Hospital

Campbelltown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Westmead Hospital

Northmead, New South Wales, Australia

And 521 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (621)