A Study of Tersolisib (LY4064809) and Abemaciclib With Hormone Therapies in Participants With PIK3CA-Mutated Early Breast Cancer

ClinicalTrials.gov ID: NCT07935317

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Official title

A Phase 2, Open-label, Randomized Study Investigating the Tolerability of Concurrent Versus Staggered Administration of Abemaciclib and Endocrine Therapy With Tersolisib in Patients With HR+, HER2- Node-Positive, PIK3CA-Mutated Early Breast Cancer.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main purpose of this study is to compare two ways of giving the anti-cancer medicines abemaciclib and hormone therapy with tersolisib in participants with early breast cancer that has a genetic mutation (PIK3CA mutation). For each participant, the study will last up to 56 weeks and include 12 visits.

Study identification

NCT ID: NCT07935317
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Eli Lilly and Company; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Breast Neoplasms

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2026 (Estimated)
Primary completion: Dec 2027 (Estimated)
Completion: Jan 2028 (Estimated)
Last update posted: Nov 13, 2026

2026 – 2028

United States locations

U.S. sites: 9
U.S. states: 7
U.S. cities: 9

Facility	City	State	ZIP	Site status
Cancer and Blood Specialty Clinic	Los Alamitos	California	90720	—
USO - Rocky Mountain Cancer Centers	Lakewood	Colorado	80228	—
Winship Cancer Institute, Emory University	Atlanta	Georgia	30308	—
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	—
Stefanie Spielman Comprehensive Breast Center	Columbus	Ohio	43212	—
Texas Oncology - West Texas	Amarillo	Texas	79106	—
Texas Oncology - Balcones	Austin	Texas	78731	—
South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas	78229-3307	—
USO - Virginia Cancer Specialists	Reston	Virginia	20190	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07935317, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 13, 2026 · Synced Nov 13, 2026