Tersolisib with Other Treatments for Advanced Breast Cancer

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

Recruiting Phase 3 Interventional Study
Breast Neoplasms Neoplasm Metastasis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for people with advanced breast cancer that has a specific genetic change. Participants will receive Tersolisib along with other cancer treatments, and they can continue as long as the treatment is effective and manageable.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with advanced breast cancer.
  • I have a specific genetic change called PIK3CA.
  • I am willing to use contraception during the trial.
  • I have measurable disease or bone disease that can be evaluated.
  • I am assigned female at birth and can use ovarian suppression if needed.
  • I am assigned male at birth and have ER+ breast cancer, agreeing to hormone suppression.
  • I have not received more than 2 prior treatments for advanced breast cancer depending on the trial part I am in.

You may not be able to join if

  • I have Type 1 or Type 2 diabetes that is not controlled.
  • I have inflammatory or metaplastic breast cancer.
  • I have a history of leptomeningeal disease or related issues.
  • I have untreated central nervous system metastases.
  • I have received antineoplastic therapy or experimental treatment in the last 14 days.
  • I am currently taking chronic steroids or have an immunodeficiency.
  • I am pregnant, breastfeeding, or plan to become pregnant during the trial.
  • I have an active infection that has not healed.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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. * If assigned female at birth, pre-/peri- and postmenopausal statu…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT