Health Trials

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

ConditionsBreast NeoplasmsNeoplasm Metastasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 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.

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.

Have histologically or cytologically confirmed breast cancer, defined as individuals with

Disqualifiers

Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter [mmol/L]), or requiring insulin.

Have inflammatory or metaplastic breast cancer.

History of leptomeningeal disease or carcinomatous meningitis.

Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4064809

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

  • Ribociclib

    Drug

    Administered orally

  • Palbociclib

    Drug

    Administered orally

  • Abemaciclib

    Drug

    Administered orally

  • Anastrozole

    Drug

    Administered orally

  • Letrozole

    Drug

    Administered orally

  • Exemestane

    Drug

    Administered orally

  • Fulvestrant

    Drug

    Administered intramuscular

Treatment groups

800 Participants
are divided into 3 treatment groups
Group A: LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1)Experimental treatment 8 interventions
Group B: LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)Experimental treatment 8 interventions
Group C: Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)Placebo comparator 8 interventions

Trial outcomes

Primary outcomes

1

(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)

As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

Time frame
Baseline through disease progression or death (Estimated up to 5 years)
2

(Part 2): Progression-Free Survival

Investigator-assessed

Time frame
Baseline to objective progression or death due to any cause (Estimated up to 5 years)

Secondary outcomes

1

(Part 1): Disease Control Rate (DCR)

per RECIST v1.1

Time frame
Baseline through measured progressive disease (Estimated up to 5 years)
2

(Part 1): Time to Response (TTR)

per RECIST v1.1

Time frame
Baseline until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 5 years)
3

(Parts 1 and 2): Duration of Response (DOR)

per RECIST v1.1

Time frame
Date of CR or PR to date of objective disease progression or death due to any cause (Estimated up to 5 years)
4

(Part 1): PFS

per RECIST v1.1

Time frame
Baseline to objective progression or death due to any cause (Estimated up to 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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