Breast Cancer Clinical Trial
— EMBER-2Official title:
EMBER-2: A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Post-menopausal Women With Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Verified date | March 2023 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | November 11, 2022 |
Est. primary completion date | November 11, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Brussel - Capital | |
Belgium | Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | |
France | Hôpital René Huguenin | Saint-Cloud | Hauts-de-Seine |
Germany | Universitätsklinikum Erlangen | Erlangen | Bayern |
Germany | Klinikum der Universitaet Muenchen | Muenchen | |
Germany | Helios Kliniken Schwerin | Schwerin | Mecklenburg-Vorpommern |
Spain | Hospital Clinic I Provincial | Barcelona | |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | Hospital Madrid Norte Sanchinarro | Madrid | |
United Kingdom | Barts Cancer Institute | London | London City |
United Kingdom | The Royal Cornwall Hospital | Truro | Cornwall |
United States | Winship Cancer Center Emory University | Atlanta | Georgia |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | 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 | Sarah Cannon Research Institute SCRI | Nashville | Tennessee |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Belgium, France, Germany, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in ER Expression | ER expression measured by H-score immunohistochemistry (IHC) | Baseline, Day 15 | |
Secondary | Change from Baseline in Ki-67 Index | Ki-67 index measured by percentage positive scoring by IHC | Baseline, Day 15 | |
Secondary | Change from Baseline in Progesterone Receptor (PR) Expression | PR expression measured by H-score IHC | Baseline, Day 15 | |
Secondary | PK: Plasma Concentration of LY3484356 | Baseline through follow-up at Day 15 |
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