Current partner codePEPTIDESDE
NCT04961996·Phase 3·INTERVENTIONAL

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)

Status

Active, not recruiting

Phase

Phase 3

Enrollment

4,170

Locations

622

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jul 14, 2021

  2. Study start

    Aug 27, 2021

  3. Primary completion

    Aug 8, 2025

  4. Study completion

    Sep 30, 2033

  5. Results posted

    Not reported

  6. Registry updated

    Jun 17, 2026

Outcomes

What the study measures.

Primary 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)

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

622 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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