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A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
812 patients around the world
Available in Brazil, Colombia, Argentina, Mexico, United States
Hoffmann-La Roche
32Research sites
812Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resectionAt least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 monthsEastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1Left ventricular ejection fraction (LVEF) of at least (≥)50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)Adequate hematologic and end-organ functionFor women of childbearing potential: Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 7 months after the final dose of PhesgoFor men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 7 months after the final dose of Phesgo to avoid exposing the embryo
- Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.Prior treatment with a selective estrogen receptor degrader (SERD)Previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant settingDisease progression within 6 months of receiving adjuvant anti-HER2 therapy (such as trastuzumab, with or without pertuzumab [IV, SC, or fixed-dose combination], or ado-trastuzumab emtansine, or neratinib)Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or betterHistory of persistent Grade ≥2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapyHistory of exposure to the following cumulative doses of anthracyclines; Doxorubicin >360 mg/m2; Liposomal doxorubicin >500 mg/m2; Epirubucin >720 mg/m2; Mitoxantrone >120 mg/m2; Idarubicin >90 mg/m2.Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal diseaseDyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapyPregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the final dose of Phesgo (Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of induction therapy).Treated with investigational therapy within 28 days prior to initiation of induction therapyTreated with localized palliative radiotherapy within 14 days prior to initiation of induction therapyConcurrent participation in any other therapeutic clinical trialKnown hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodiesCurrent chronic daily treatment (continuous for >3 months) with corticosteroids (dose of 10 mg/day methylprednisolone or equivalent)Poorly controlled hypertensionKnown clinically significant history of liver disease consistent with Child-Pugh Class B or C, active liver disease including active viral or other hepatitis virus, autoimmune hepatic disorders, or sclerosing cholangitis, current alcohol abuse, or cirrhosisActive cardiac disease or history of cardiac dysfunctionMajor surgical procedure or significant traumatic injury within 14 days prior to enrollment or anticipation of need for major surgery during induction therapyActive inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgeryConcurrent, serious, uncontrolled infections, or known infection with HIV with the following exception: Individuals who are HIV positive are eligible provided they are stable on anti-retroviral therapy for ≥4 weeks, have a CD4 count ≥350 cells/uL, and have an undetectable viral load and no history of AIDS-defining opportunistic infections within 12 months prior to enrollment.Serious COVID-19 infection within 14 days prior to enrollment; however, no screening testing for SARS-CoV-2 is requiredSerious infection requiring oral or IV antibiotics within 7 days prior to screeningAny serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in the studyHistory of malignancy within 5 years prior to screening with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or deathFor pre- and perimenopausal women, and men: Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa); Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of endocrine therapy that requires gonadal function suppressionTreatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of giredestrant treatment in Arm BA documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism, including deep vein thrombosis, unless the condition is adequately treated and under control
Sites
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Consultorios Médicos Dr. Isaac Scherbovsky - Mendoza
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Centro Oncológico Korben
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Pronutrir Nutrição
Recruiting
StudyheredERA
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05296798
