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NCT05307705 · ClinicalTrials.gov registry record · Phase 1

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

A Phase 1 study of Breast Cancer, sponsored by Eli Lilly and Company.

Active
Registry status
Phase 1
Development phase
193
Enrollment target
20
Study locations

NCT05307705: Active Phase 1 study of Breast Cancer, sponsored by Eli Lilly and Company.

NCT05307705 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 193 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05307705, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
193 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

Primary Outcome

Number of patients with DLTs

Conditions Studied

Interventions

  • DRUG Fulvestrant
  • DRUG Abemaciclib
  • DRUG Imlunestrant
  • DRUG LOXO-783
  • DRUG Anastrozole, Exemestane, or Letrozole

Study Locations (20)

Texas

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center - Dallas
  • UT Southwestern Medical Center - Dallas
  • University of Texas MD Anderson Cancer Center - Houston
  • South Texas Accelerated Research Therapeutics (START) - San Antonio

California

  • UCLA Medical Center - Los Angeles
  • UCSF Medical Center at Mission Bay - San Francisco
  • Stanford University Hospital - Stanford

Other

  • Cancer Research SA - Adelaide
  • Peter Maccallum Cancer Institute Erb - East Melbourne
  • St Vincent's Hospital - Sydney

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

New York

  • Memorial Sloan Kettering Cancer Center - New York
  • Wilmot Cancer Institute - Rochester

Arizona

  • Mayo Clinic of Scottsdale - Scottsdale

Florida

  • Mayo Clinic - Jacksonville

Georgia

  • Winship Cancer Center Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 193 participants
Start Date 2022-05-11
Est. Completion 2026-12
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the registry record for NCT05307705 still lists

NCT05307705 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.

NCT05307705 names 20 study sites across 11 states, led by Texas, California, Other.

Frequently Asked Questions

What is clinical trial NCT05307705 about?

NCT05307705 is a clinical study titled "A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors". The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and...

What is the current status of trial NCT05307705?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 193 participants. The study started on 2022-05-11. Estimated completion is 2026-12.

What conditions does trial NCT05307705 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05307705?

The interventions under investigation include: Fulvestrant (DRUG), Abemaciclib (DRUG), Imlunestrant (DRUG), LOXO-783 (DRUG), Anastrozole, Exemestane, or Letrozole (DRUG).

Who is sponsoring clinical trial NCT05307705?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05307705 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05307705's enrollment target sits among peer trials

193 389th of 1224 higher than 836 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05307705, the US trial registry maintained by the National Library of Medicine. NCT05307705 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.