A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
- Registration Number
- NCT04647487
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 86
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3484356 Dose Level 1 LY3484356 Administered orally. LY3484356 Dose Level 2 LY3484356 Administered orally. LY3484356 Dose Level 3 LY3484356 Administered orally.
- Primary Outcome Measures
Name Time Method Change from Baseline in ER Expression Baseline, Day 15 ER expression measured by H-score immunohistochemistry (IHC)
- Secondary Outcome Measures
Name Time Method Change from Baseline in Ki-67 Index Baseline, Day 15 Ki-67 index measured by percentage positive scoring by IHC
Change from Baseline in Progesterone Receptor (PR) Expression Baseline, Day 15 PR expression measured by H-score IHC
PK: Plasma Concentration of LY3484356 Baseline through follow-up at Day 15
Trial Locations
- Locations (19)
Northwestern Memorial Hosptial
🇺🇸Chicago, Illinois, 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
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Winship Cancer Center Emory University
🇺🇸Atlanta, Georgia, United States
The Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Sarah Cannon Research Institute SCRI
🇺🇸Nashville, Tennessee, United States
Helios Kliniken Schwerin
🇩🇪Schwerin, Mecklenburg-Vorpommern, Germany
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Institut Jules Bordet
🇧🇪Brussel - Capital, Belgium
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Klinikum der Universitaet Muenchen
🇩🇪Muenchen, Germany
Hospital Clinic I Provincial
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Barts Cancer Institute
🇬🇧London, London City, United Kingdom
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hospital Madrid Norte Sanchinarro
🇪🇸Madrid, Spain
Hôpital René Huguenin
🇫🇷Saint-Cloud, Hauts-de-Seine, France