A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

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A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07174336
Protocol IDs
27726
J6M-MC-JSGD ( Other Identifier ) (OTHER: Eli Lilly
2025-522791-92-00 ( EU Trial (CTIS) Number )
Study Sponsor
Eli Lilly and Company

Summary

The purpose of the study is to assess the efficacy and safety of the addition of
Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced
hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-)
breast cancer. Participants can remain in the study as long as the drug is helping the
cancer without unbearable side effects.

Eligibility

  1. Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
  2. If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.
  3. If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.
  4. Have histologically or cytologically confirmed breast cancer, defined as individuals with
  5. locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
  6. hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
  7. HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (=)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
  8. HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
  9. Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
  10. Have measurable disease or non-measurable, evaluable bone disease
  11. Part 1:
  12. Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
  13. Up to 1 of these prior systemic treatments may contain chemotherapy
  14. Part 2:
  15. Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
  16. Individuals who are eligible are either
  17. Population 1 (P1): Endocrine sensitive
  18. newly diagnosed with advanced breast cancer (de novo)
  19. participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET
  20. relapsed with documented evidence of progression greater than (>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or
  21. Population 2 (P2): Endocrine resistant
  22. relapsed with documented evidence of progression less than or equal to (=)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor.
  23. if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be >12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy.

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**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.