LY4064809 for Breast Cancer

Recruiting at 186 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must be taking: GnRH agonists

Must not be taking: Insulin, Anticonvulsants, Corticosteroids

Disqualifiers: Diabetes, Inflammatory breast cancer, CNS metastases, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Estimated up to 5 years

920 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY4064809, to evaluate its effectiveness alongside other treatments for a specific type of advanced breast cancer. It focuses on breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), meaning the cancer grows in response to hormones but lacks extra HER2 proteins. The trial examines whether adding LY4064809 can halt cancer growth without causing unbearable side effects. Individuals with advanced HR+/HER2- breast cancer and a PIK3CA mutation (a specific gene change) might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering early access to a potentially effective treatment.

Do I need to stop my current medications to join the trial?

The trial requires a washout period (time without taking certain medications) of up to 28 days for any local or systemic cancer treatments before starting the study. It's best to discuss your specific medications with the trial team to see if they need to be stopped.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LY4064809 was tested in earlier studies to assess its safety alongside other cancer treatments. Most patients in these studies tolerated LY4064809 well. Many experienced mild to moderate side effects, common with cancer treatments, such as nausea and tiredness, but most managed them effectively.

This study is in a later phase, indicating that LY4064809 has already passed initial safety tests in earlier trials. This suggests the treatment is considered safe enough for a larger group. However, participants might still experience side effects, so discussing any concerns with the study team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

LY4064809 is unique because it combines a novel active ingredient with existing treatments like CDK4/6 inhibitors and endocrine therapy, potentially enhancing their effectiveness against breast cancer. Unlike standard options, which typically focus on halting cancer cell growth, LY4064809 is designed to target specific pathways that may improve treatment outcomes. Researchers are excited about this treatment because it offers a new mechanism of action that could work alongside current therapies to better combat the disease.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that LY4064809, one of the treatments in this trial, may help treat advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative when combined with CDK4/6 inhibitors and hormone therapy. Earlier studies designed this combination to specifically slow cancer cell growth, which is crucial for disease control. Initial results suggested that patients taking LY4064809 experienced a noticeable reduction in tumor size compared to those who did not. This trial will compare LY4064809 with a placebo, both combined with CDK4/6 inhibitors and endocrine therapy, to evaluate its effectiveness. LY4064809 could be a valuable addition to current breast cancer treatments. However, it is important to weigh the benefits against possible side effects, as with any medical treatment. ^{1 3 5 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with advanced hormone receptor-positive, HER2-negative breast cancer that has a specific genetic change (PIK3CA). They should not have had prior treatments for their advanced cancer. Participants must be able to take oral medication and willing to undergo biopsies.

Inclusion Criteria

I am female and willing to use hormone therapy if I am pre- or peri-menopausal.

I agree to hormone therapy if my breast cancer is estrogen receptor positive.

My breast cancer is advanced, cannot be cured by surgery, and tests positive for hormone receptors but not HER2.

Exclusion Criteria

I have diabetes with high blood sugar or need insulin.

My breast cancer is either inflammatory or metaplastic.

I have had cancer spread to the lining of my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4064809 in combination with a CDK4/6 inhibitor and endocrine therapy

Estimated up to 5 years

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

Estimated up to 5 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term if the drug is helping without unbearable side effects

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• LY4064809

Trial Overview The study tests LY4064809 combined with other anti-cancer drugs like Ribociclib, Palbociclib, Abemaciclib, Exemestane, Letrozole, Anastrozole or Fulvestrant against a placebo. The goal is to see if LY4064809 can improve treatment outcomes as the first line of defense.

How Is the Trial Designed?

Group I: LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2) Experimental Treatment 6 Interventions

LY4064809 given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly

Group II: LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1) Experimental Treatment 8 Interventions

LY4064809 given orally in one of two doses in combination with investigator's choice of CDK4/6 inhibitor given orally and ET given orally or intramuscularly

Group III: Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2) Placebo Group 6 Interventions

Placebo given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07174336

A Study of LY4064809 With Other Anti-Cancer Treatments ... The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for ...

2. firstwordpharma.com firstwordpharma.com/story/6320946

Lilly to present new clinical data for Verzenio (abemaciclib ... In a late-breaking oral presentation, Lilly will share updated results from the Phase 1/2 PIKALO-1 trial, a study of LY4064809 (STX-478), a pan- ...

3. withpower.com withpower.com/trial/phase-3-breast-neoplasms-9-2025-cab27

LY4064809 for Breast Cancer · Info for Participants The purpose of the study is to assess the efficacy and safety of the addition of LY4064809 to other anti-cancer drugs as first treatment for advanced ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/breast-cancer

UCSF Breast Cancer Clinical Trials — San Francisco Bay ... This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team ...

5. tipranks.com tipranks.com/news/company-announcements/eli-lillys-new-phase-3-study-a-potential-game-changer-in-advanced-breast-cancer-treatment

Eli Lilly's New Phase 3 Study: A Potential Game-Changer ... The study tests LY4064809, an oral drug, in combination with CDK4/6 inhibitors and endocrine therapy. These treatments are designed to target ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/394035

First-in-Human Study of STX-478 as Monotherapy and ... Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02413

First-in-Human Study of STX-478 as Monotherapy and ... Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary ...