A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

  • Cancer
  • Breast Cancer
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Not yet recruiting

This study runs in
N/A
Study Identifier:

NCT06790693 2024-516162-11-00 WO45654

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT06790693, WO45654, 2024-516162-11-00 Study Identifier
      Inavolisib, Placebo, CDK4/6i, Letrozole Treatments
      Breast Cancer Condition
      Official Title

      A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Women or men with histologically or cytologically confirmed carcinoma of the breast
      • Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
      • Documented HER2-negative tumor according to ASCO/CAP guidelines
      • De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
      • Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
      • Confirmation of biomarker eligibility
      • Consent to provide fresh or archival tumor tissue specimen
      • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
      • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
      Exclusion Criteria
      • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
      • Metaplastic breast cancer
      • Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
      • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
      • Any history of leptomeningeal disease or carcinomatous meningitis
      • Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
      • Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
      • Symptomatic active lung disease
      • History of or active inflammatory bowel disease
      • Any active bowel inflammation
      • Prior hematopoietic stem cell or bone marrow transplantation
      • Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

      For the latest version of this information please go to www.forpatients.roche.com

       

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