A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
Completed · Phase 1
Conditions studied: Breast Cancer
In brief
The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.
Key facts
- Study ID
- NCT04647487
- Run by
- Eli Lilly and Company
- People needed
- 87
- Starts
- 2021-04-21
- Expected to finish
- 2022-11-11
- Last updated by the study team
- 2025-11-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Have histologically confirmed invasive ER+, HER2- breast carcinoma
- Be willing and able to provide pre- and on-treatment tumor samples
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
- Have adequate organ function
- Be able to swallow capsules
- Be a postmenopausal woman
You may not qualify if…
- Have bilateral invasive breast cancer
- Have metastatic breast cancer
- Plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer therapy
- Have had prior therapy (of any kind) for an invasive or non-invasive breast cancer
- Have had prior radiotherapy to the ipsilateral chest wall for any malignancy
- Have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer
- Have had prior hormone-replacement therapy within 4 weeks of the start of study treatment
- Have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s)
- Have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
- Have another serious medical condition
- Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
Where it is running
- Winship Cancer Center Emory University — Atlanta, Georgia, United States
- Northwestern Memorial Hosptial — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States
- Baylor College of Medicine — Houston, Texas, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- University of Vermont Medical Center — Burlington, Vermont, United States
- Institut Jules Bordet — Brussel - Capital, Belgium
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg — Leuven, Belgium
- Hôpital René Huguenin — Saint-Cloud, Hauts-de-Seine, France
- Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany
- Helios Kliniken Schwerin — Schwerin, Mecklenburg-Vorpommern, Germany
- Klinikum der Universitaet Muenchen — München, Germany
- Hospital Clinic I Provincial — Barcelona, Spain
- Hospital General Universitario Gregorio Marañon — Madrid, Spain
- Hospital Madrid Norte Sanchinarro — Madrid, Spain
- The Royal Cornwall Hospital — Truro, Cornwall, United Kingdom
- Barts Cancer Institute — London, London City, United Kingdom
Full record on ClinicalTrials.gov
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