JOURNAL ONKOLOGIE – STUDIE
EMBER-2 A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
Noch nicht rekrutierend
NCT-Nummer:
NCT04647487
Studienbeginn:
Februar 2021
Letztes Update:
21.02.2021
Wirkstoff:
LY3484356
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
Eli Lilly and Company
Collaborator:
-
Studienleiter
Study Director
Eli Lilly and Company
Kontakt
Kontakt:
Phone: 1-317-615-4559
E-Mail: ClinicalTrials.gov@lilly.com» Kontaktdaten anzeigen
Studienlocations (3 von 22)
Hautkrebszentrum Universitätsklinikum Erlangen
Ulmenweg 18
91054 Erlangen
(Bayern)
Deutschland» Google-Maps
Ansprechpartner:
Phone: 004991318533553» Ansprechpartner anzeigenBrustzentrum am Klinikum der Universität München
Marchioninistraße 15
80337 München
Deutschland» Google-Maps
Ansprechpartner:
Phone: 00498951604317» Ansprechpartner anzeigenHelios Kliniken Schwerin
19049 Schwerin
(Mecklenburg-Vorpommern)
Germany» Google-Maps
Ansprechpartner:
Phone: 00493855202300» Ansprechpartner anzeigen
Ulmenweg 18
91054 Erlangen
(Bayern)
Deutschland» Google-Maps
Ansprechpartner:
Phone: 004991318533553» Ansprechpartner anzeigenBrustzentrum am Klinikum der Universität München
Marchioninistraße 15
80337 München
Deutschland» Google-Maps
Ansprechpartner:
Phone: 00498951604317» Ansprechpartner anzeigenHelios Kliniken Schwerin
19049 Schwerin
(Mecklenburg-Vorpommern)
Germany» Google-Maps
Ansprechpartner:
Phone: 00493855202300» Ansprechpartner anzeigen
Cedars Sinai Medical Center
90048 Los Angeles
United States» Google-Maps
Ansprechpartner:
Phone: 310-967-2700» Ansprechpartner anzeigenWinship Cancer Center Emory University
30322 Atlanta
United States» Google-Maps
Ansprechpartner:
Phone: 4047781900» Ansprechpartner anzeigenNorthwestern University
60611 Chicago
United States» Google-Maps
Ansprechpartner:
Phone: 312-503-2899» Ansprechpartner anzeigenMassachusetts General Hospital
02114 Boston
United States» Google-Maps
Ansprechpartner:
Phone: 617-643-2208» Ansprechpartner anzeigenWashington University School of Medicine
63110 Saint Louis
United States» Google-Maps
Ansprechpartner:
Phone: 314-747-0063» Ansprechpartner anzeigenSarah Cannon Research Institute SCRI
37203 Nashville
United States» Google-Maps
Ansprechpartner:
Phone: 615-329-7274» Ansprechpartner anzeigenTennessee Oncology PLLC
37203 Nashville
United States» Google-Maps
Ansprechpartner:
Phone: 615-329-7274» Ansprechpartner anzeigenBaylor College of Medicine
77030 Houston
United States» Google-Maps
Ansprechpartner:
Phone: 7137988237» Ansprechpartner anzeigenUniversity of Texas MD Anderson Cancer Center
77030 Houston
United States» Google-Maps
Ansprechpartner:
Phone: 713-792-7216» Ansprechpartner anzeigenUniversity of Wisconsin-Madison Hospital and Health Clinic
53792-4108 Madison
United States» Google-Maps
Ansprechpartner:
Phone: 608-265-9701» Ansprechpartner anzeigenInstitut Jules Bordet
1000 Brussel
Belgium» Google-Maps
Ansprechpartner:
Phone: 003225413189» Ansprechpartner anzeigenUniversitaire Ziekenhuizen Leuven - Campus Gasthuisberg
3000 Leuven
Belgium» Google-Maps
Ansprechpartner:
Phone: 003216344634» Ansprechpartner anzeigenCentre Rene Huguenin - Institut Curie
92210 Saint Cloud
France» Google-Maps
Ansprechpartner:
Phone: 0033147111515» Ansprechpartner anzeigenHospital Clinic I Provincial
08036 Barcelona
Spain» Google-Maps
Ansprechpartner:
Phone: 0034932275402» Ansprechpartner anzeigenHospital General Universitario Gregorio Marañon
28007 Madrid
Spain» Google-Maps
Ansprechpartner:
Phone: 0034915868115» Ansprechpartner anzeigenHospital Madrid Norte Sanchinarro
28050 Madrid
Spain» Google-Maps
Ansprechpartner:
Phone: 0034917567984» Ansprechpartner anzeigenThe Royal Cornwall Hospital
TR1 3LJ Truro
United Kingdom» Google-Maps
Ansprechpartner:
Phone: 00441872258304» Ansprechpartner anzeigenBarts Cancer Institute
EC1A 7BE London
United Kingdom» Google-Maps
Ansprechpartner:
Phone: 00442078823442» Ansprechpartner anzeigenWestern General Hospital
EH4 2XU Edinburgh
United Kingdom» Google-Maps
Ansprechpartner:
Phone: 00441315372907» Ansprechpartner anzeigen
Alle anzeigen 90048 Los Angeles
United States» Google-Maps
Ansprechpartner:
Phone: 310-967-2700» Ansprechpartner anzeigenWinship Cancer Center Emory University
30322 Atlanta
United States» Google-Maps
Ansprechpartner:
Phone: 4047781900» Ansprechpartner anzeigenNorthwestern University
60611 Chicago
United States» Google-Maps
Ansprechpartner:
Phone: 312-503-2899» Ansprechpartner anzeigenMassachusetts General Hospital
02114 Boston
United States» Google-Maps
Ansprechpartner:
Phone: 617-643-2208» Ansprechpartner anzeigenWashington University School of Medicine
63110 Saint Louis
United States» Google-Maps
Ansprechpartner:
Phone: 314-747-0063» Ansprechpartner anzeigenSarah Cannon Research Institute SCRI
37203 Nashville
United States» Google-Maps
Ansprechpartner:
Phone: 615-329-7274» Ansprechpartner anzeigenTennessee Oncology PLLC
37203 Nashville
United States» Google-Maps
Ansprechpartner:
Phone: 615-329-7274» Ansprechpartner anzeigenBaylor College of Medicine
77030 Houston
United States» Google-Maps
Ansprechpartner:
Phone: 7137988237» Ansprechpartner anzeigenUniversity of Texas MD Anderson Cancer Center
77030 Houston
United States» Google-Maps
Ansprechpartner:
Phone: 713-792-7216» Ansprechpartner anzeigenUniversity of Wisconsin-Madison Hospital and Health Clinic
53792-4108 Madison
United States» Google-Maps
Ansprechpartner:
Phone: 608-265-9701» Ansprechpartner anzeigenInstitut Jules Bordet
1000 Brussel
Belgium» Google-Maps
Ansprechpartner:
Phone: 003225413189» Ansprechpartner anzeigenUniversitaire Ziekenhuizen Leuven - Campus Gasthuisberg
3000 Leuven
Belgium» Google-Maps
Ansprechpartner:
Phone: 003216344634» Ansprechpartner anzeigenCentre Rene Huguenin - Institut Curie
92210 Saint Cloud
France» Google-Maps
Ansprechpartner:
Phone: 0033147111515» Ansprechpartner anzeigenHospital Clinic I Provincial
08036 Barcelona
Spain» Google-Maps
Ansprechpartner:
Phone: 0034932275402» Ansprechpartner anzeigenHospital General Universitario Gregorio Marañon
28007 Madrid
Spain» Google-Maps
Ansprechpartner:
Phone: 0034915868115» Ansprechpartner anzeigenHospital Madrid Norte Sanchinarro
28050 Madrid
Spain» Google-Maps
Ansprechpartner:
Phone: 0034917567984» Ansprechpartner anzeigenThe Royal Cornwall Hospital
TR1 3LJ Truro
United Kingdom» Google-Maps
Ansprechpartner:
Phone: 00441872258304» Ansprechpartner anzeigenBarts Cancer Institute
EC1A 7BE London
United Kingdom» Google-Maps
Ansprechpartner:
Phone: 00442078823442» Ansprechpartner anzeigenWestern General Hospital
EH4 2XU Edinburgh
United Kingdom» Google-Maps
Ansprechpartner:
Phone: 00441315372907» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
Inclusion Criteria:Participant Must:
- 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
Exclusion Criteria:
Participant Must Not:
- 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)
- Be pregnant or breastfeeding
- Have certain infections such as hepatitis or tuberculosis or HIV that are not well
controlled
- Have another serious medical condition
Studien-Rationale
Primary outcome:1. Change from Baseline in ER Expression (Time Frame - Baseline, Day 15):
ER expression measured by H-score immunohistochemistry (IHC)
Secondary outcome:
1. Change from Baseline in Ki-67 Index (Time Frame - Baseline, Day 15):
Ki-67 index measured by percentage positive scoring by IHC
2. Change from Baseline in Progesterone Receptor (PR) Expression (Time Frame - Baseline, Day 15):
PR expression measured by H-score IHC
3. PK: Plasma Concentration of LY3484356 (Time Frame - Baseline through follow-up at Day 15)
Studien-Arme
- Experimental: LY3484356 Dose Level 1
Administered orally. - Experimental: LY3484356 Dose Level 2
Administered orally.
Geprüfte Regime
- LY3484356:
Administered orally.
Quelle: ClinicalTrials.gov