A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (NCT05307705)

🧪 Interventions in This Study

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

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)
2. Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
3. Have stopped all cancer treatment and have recovered from the major side effects
4. Have adequate organ function, as measured by blood tests
5. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
6. Patients must have
7. Measurable disease \--- Patients with non-breast tumor types must have at least 1 measurable lesion
8. Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)
9. For patients with an estrogen receptor (ER)+ breast cancer diagnosis:
10. If female, must be postmenopausal
11. If male, must agree to use hormone suppression
12. Phase 1a: \-- Dose escalation and backfill patients:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (50 Sites)

Showing the first 25 of 50 sites.

• Mayo Clinic of Scottsdale — Scottsdale, Arizona
• UCLA Medical Center — Los Angeles, California
• UCSF Medical Center at Mission Bay — San Francisco, California
• Stanford University Hospital — Stanford, California
• Mayo Clinic — Jacksonville, Florida
• Winship Cancer Center Emory University — Atlanta, Georgia
• Massachusetts General Hospital — Boston, Massachusetts
• Dana-Farber Cancer Institute — Boston, Massachusetts
• Mayo Clinic — Rochester, Minnesota
• Washington University Medical School — St Louis, Missouri
• Memorial Sloan Kettering Cancer Center — New York, New York
• Wilmot Cancer Institute — Rochester, New York
• Tennessee Oncology PLLC — Nashville, Tennessee
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas
• UT Southwestern Medical Center — Dallas, Texas
• University of Texas MD Anderson Cancer Center — Houston, Texas
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas
• Cancer Research SA — Adelaide,
• Peter Maccallum Cancer Institute Erb — East Melbourne,
• St Vincent's Hospital — Sydney,
• Institut Jules Bordet — Anderlecht,
• Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg — Leuven,
• Princess Margaret Hospital (Hong Kong) — Toronto,
• BC Cancer Vancouver — Vancouver,
• Beijing Cancer hospital — Beijing,

📞 Contact the Study Coordinator

Phone: (317) 615-4559

Email: ClinicalTrials.gov@lilly.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Breast Cancer

• S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer — Anniston, Alabama
• Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer — Columbia, Maryland
• [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
• Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
• TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
• A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer — Los Angeles, California

Explore by condition: All Breast Cancer clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.