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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)
4200 patients around the world
Available in Chile, Mexico, United States, Spain, Argentina
Hoffmann-La Roche
149Research sites
4200Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimenParticipants 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 negativityParticipants 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 surgeryParticipants 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 protocolEastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2Able and willing to swallow, retain, and absorb oral medicationAdequate organ functionTo be eligible for substudy participation, in addition to meeting the inclusion criteria in the primary protocol, participants must also meet the following modified criteria:Patients who received adjuvant radiotherapy must have completed radiotherapy prior to enrollment, and patients must have recovered (to Grade ≤1) from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment.
- 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 choiceReceived 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 studyReceiving 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 dysfunctionDiagnosed with Stage IV breast cancerA 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 cancerAny 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 hepatitisTreatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatmentKnown allergy or hypersensitivity to any of the study drugs or any of their excipientsPre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonistsA documented history of hemorrhagic diathesis, coagulopathy, or thromboembolismRenal dysfunction that requires dialysisA major surgical procedure unrelated to breast cancer within 28 days prior to randomizationA 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 screeningAny 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 studyUnable or unwilling to comply with the requirements of the protocol in the opinion of the investigatorPotential participants are excluded from the substudy if any criteria from t he primary study or the following criteria apply:Prior participation in the GO42784 primary studyReceived a CDK4/6i as (neo)adjuvant therapy prior to enrollmentTreatment with moderate CYP3A inducers, strong CYP3A inducers or strong CYP3A inhibitors within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
Sites
Instituto de Diagnóstico e Investigaciones Metabólicas - IDIM - sede centro - CABA
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Instituto de Especialidades de la Salud Rosario Clínica del Tórax
Centro Médico Privado CEMAIC - Córdoba
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Instituto de Investigaciones Clínicas Mar del Plata
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Centro Médico Privado de Reumatología - San Miguel de Tucumán
Organización Médica de Investigación (OMI)
Hospital Privado de la Comunidad
StudylidERA
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04961996
