Clinical trial NCT04647487: A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: SERD
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in ER Expression
timeFrame: Baseline, Day 15
Secondary outcomes:
measure: Change from Baseline in Ki-67 Index
timeFrame: Baseline, Day 15
measure: Change from Baseline in Progesterone Receptor (PR) Expression
timeFrame: Baseline, Day 15
measure: PK: Plasma Concentration of LY3484356
timeFrame: Baseline through follow-up at Day 15
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Center Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hosptial
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Brussel - Capital
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Saint-Cloud
country: France
facility: Hôpital René Huguenin
state: Hauts-de-Seine
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
state: Mecklenburg-Vorpommern
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital
state: Cornwall
city: London
country: United Kingdom
facility: Barts Cancer Institute
state: London City
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: