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).
Status
Active, not recruiting
Phase
Phase 3
Enrollment
4,170
Locations
622
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
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
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
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.
Timeline
First posted
Jul 14, 2021
Study start
Aug 27, 2021
Primary completion
Aug 8, 2025
Study completion
Sep 30, 2033
Results posted
Not reported
Registry updated
Jun 17, 2026
Outcomes
Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers
Time frame · From randomization to first occurrence of an IDFS event (up to 10 years)
Overall Survival
Time frame · From randomization to death from any cause (up to 10 years)
Invasive Disease-Free Survival (IDFS), Including Second Primary Non-Breast Cancers
Time frame · From randomization to first occurrence of an IDFS event (up to 10 years)
Disease-Free Survival (DFS)
Time frame · From randomization to first occurrence of a DFS event (up to 10 years)
Distant Recurrence-Free Interval (DRFI)
Time frame · From randomization to first occurrence of a DFRI event (up to 10 years)
Locoregional Recurrence-Free Interval (LRRFI)
Time frame · From randomization to first occurrence of a LRRFI event (up to 10 years)
Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame · Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Change from Baseline in the Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Time frame · Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Time frame · Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Change from Baseline in the Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Time frame · Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Time frame · Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Eligibility
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
Study locations
Argentina · Australia · Austria · Belgium · Bosnia and Herzegovina · Brazil · Bulgaria · Canada · Chile · China · Colombia · Costa Rica · Croatia · Czechia · Egypt · Finland · France · Georgia · Germany · Greece · Guatemala · Hong Kong · Hungary · India · Ireland · Israel · Italy · Japan · Kenya · Latvia · Malaysia · Mexico · Netherlands · North Macedonia · Peru · Philippines · Poland · Portugal · Romania · Serbia · Slovakia · Slovenia · South Africa · South Korea · Spain · Sweden · Switzerland · Taiwan · Thailand · Turkey (Türkiye) · Uganda · Ukraine · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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 Blood and Specialty Clinic
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
Publications
No PMID-linked publications were present in this registry snapshot.
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