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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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06790693
Protocol IDs
WO45654 (primary)
NCI-2025-02679
2024-516162-11-00
Study Sponsor
Hoffmann-La Roche

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).

Eligibility

  1. Women or men with histologically or cytologically confirmed carcinoma of the breast
  2. Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  3. Documented HER2-negative tumor according to ASCO/CAP guidelines
  4. 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
  5. Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
  6. Confirmation of biomarker eligibility
  7. Consent to provide fresh or archival tumor tissue specimen
  8. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  10. Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Treatment Sites in Georgia

Northwest Georgia Oncology Centers (NGOC)


340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 3060


Study Coordinator:
Kristine Parker
470-267-1480

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.