ACTIVE_NOT_RECRUITING

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)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice 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. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

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

Quick Facts

Study Start:2021-08-27

Study Completion:2035-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04961996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Southern Cancer Center

Daphne, Alabama, 36526

United States

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

Bakersfield, California, 93309

United States

Arrowhead Regional Medical Center

Colton, California, 92324

United States

Cancer and Blood Specialty Clinic

Fountain Valley, California, 92708

United States

St Joseph Heritage Healthcare

Fullerton, California, 92835

United States

Long Beach Memorial Medical Center

Long Beach, California, 90806

United States

UCLA Hematology/Oncology

Los Angeles, California, 90095

United States

Keck Medicine of USC ? Newport Beach

Newport Beach, California, 92663-4121

United States

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

Orange, California, 92868

United States

Stanford University Medical Center

Palo Alto, California, 94304

United States

Kaiser Permanente - San Diego

San Diego, California, 92120

United States

Stanford Cancer Center South Bay

San Jose, California, 95124

United States

Sansum Clinic

Santa Barbara, California, 93105

United States

Torrance Memorial Physician Network/Cancer Care

Torrance, California, 90505

United States

Kaiser Permanente - Vallejo

Vallejo, California, 94589

United States

Rocky Mountain Cancer Centers (Longmont) - USOR

Longmont, Colorado, 80501

United States

Stamford Hospital

Stamford, Connecticut, 06902

United States

University of Florida

Gainesville, Florida, 32608

United States

Memorial Healthcare System - Memorial Regional Hospital

Hollywood, Florida, 33021

United States

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, 32207

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

United States

Miami Cancer Institute of Baptist Health, Inc.

Miami, Florida, 33176

United States

Orlando Health Cancer Institute

Orlando, Florida, 32806

United States

Miami Cancer Institute-Plantation

Plantation, Florida, 33324

United States

Memorial Health University Cancer Center

Savannah, Georgia, 31404

United States

University of Chicago Hospital

Chicago, Illinois, 60637

United States

Elmhurst Cancer Center

Elmhurst, Illinois, 60126

United States

Joliet Oncology Hematology Associates, Ltd.

Joliet, Illinois, 60435

United States

Edward Cancer Center Plainfield

Plainfield, Illinois, 60585

United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403

United States

University of Iowa

Iowa City, Iowa, 52242-1086

United States

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068

United States

University of Kentucky

Lexington, Kentucky, 40536

United States

Norton Cancer Institute - MDC

Louisville, Kentucky, 40202

United States

University Medical Center New Orleans

New Orleans, Louisiana, 70112

United States

UPMC Western Maryland - Schwab Family Cancer Center

Cumberland, Maryland, 21502

United States

University of Maryland

Towson, Maryland, 21204

United States

Lahey Clinic Med Ctr

Burlington, Massachusetts, 01805

United States

University Of Michigan

Ann Arbor, Michigan, 48109

United States

Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55426

United States

University of Missouri-Columbia

Columbia, Missouri, 65203

United States

St. Vincent Frontier Cancer Center

Billings, Montana, 59102

United States

Nebraska Cancer Specialists

Omaha, Nebraska, 68130-2042

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89135

United States

Hunterdon Hematology Oncology

Flemington, New Jersey, 08822

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

United States

New York University Cancer Cen

New York, New York, 10016

United States

Stony Brook Univ Cancer Ctr

Stony Brook, New York, 11794

United States

Messino Cancer Centers

Asheville, North Carolina, 28806

United States

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Rex Cancer Center

Raleigh, North Carolina, 27607

United States

Atrium Health Wake Forest Baptist Medical Center - PPDS

Winston-Salem, North Carolina, 27157

United States

Aultman Hospital

Canton, Ohio, 44710

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Columbus NCORP

Columbus, Ohio, 43125

United States

Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, 43212

United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401

United States

Kaiser Permanente-Northwest Region

Portland, Oregon, 97227

United States

Pinnacle Health

Harrisburg, Pennsylvania, 17109

United States

Penn State Univ. Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212-4737

United States

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

Reading Hospital

West Reading, Pennsylvania, 19611

United States

Women & Infants Hospital

Providence, Rhode Island, 02905

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

West Cancer Center & Research Institute

Germantown, Tennessee, 38138-1762

United States

Texas Oncology, P.A. - El Paso

El Paso, Texas, 79902

United States

Texas Oncology (Flower Mound) - USOR

Flower Mound, Texas, 75028

United States

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, 76104

United States

Baylor College of Medicine Medical Center

Houston, Texas, 77030

United States

Houston Methodist Cancer Center

Houston, Texas, 77030

United States

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410

United States

Texas Oncology (McAllen) - USOR

McAllen, Texas, 78503

United States

Texas Oncology McKinney

McKinney, Texas, 75071

United States

Texas Oncology (Tyler) - USOR

Tyler, Texas, 75702-8363

United States

Texas Oncology (Waco) - USOR

Waco, Texas, 76712

United States

Centra Alan B. Pearson Regional Cancer Center

Lynchburg, Virginia, 24501

United States

Bon Secours Mercy Health

Midlothian, Virginia, 23114

United States

Virginia Oncology Associates

Norfolk, Virginia, 23502

United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, 23298

United States

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

Roanoke, Virginia, 24014

United States

Swedish Cancer Institute

Seattle, Washington, 98104

United States

West Virginia University Hospitals Inc

Morgantown, West Virginia, 26056

United States

University of Wisconsin

Madison, Wisconsin, 53792

United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-27

Study Completion Date2035-01-01

Study Record Updates

Study Start Date2021-08-27

Study Completion Date2035-01-01

Terms related to this study

Additional Relevant MeSH Terms

Early Breast Cancer