A Study of LY3484356 in Women With Breast Cancer Before Having Surgery

Breast Cancer Clinical Trial

— EMBER-2  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647487
• Other study ID #: 17575
• Secondary ID: J2J-MC-JZLB2020-
• Status: Completed
• Phase: Phase 1
• Start date: April 21, 2021
• Est. completion date: November 11, 2022

Study information

• Verified date: March 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• LY3484356
Administered orally.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Spain,  United Kingdom, 

Outcome

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

External Links

•   A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)