Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT04647487

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 18 Locations for this study

See Locations Near You

Winship Cancer Center Emory University
Atlanta Georgia, 30322, United States More Info
Contact
4047781900
Manali Ajay Bhave
Principal Investigator
Northwestern Memorial Hosptial
Chicago Illinois, 60611, United States More Info
Contact
312-503-2899
Swati Kulkarni
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Contact
617-643-2208
Laura Spring
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Contact
314-747-0063
Rebecca Aft
Principal Investigator
Sarah Cannon Research Institute SCRI
Nashville Tennessee, 37203, United States More Info
Erika Hamilton
Principal Investigator
Sarah Cannon Research Institute SCRI
Nashville Tennessee, 37203, United States More Info
Contact
615-329-7274
SMO Sarah Cannon Research Inst.
Principal Investigator
Baylor College of Medicine
Houston Texas, 77030, United States More Info
Contact
7137988237
Stacey Ann Carter
Principal Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Contact
713-792-7216
Kelly Hunt
Principal Investigator
University of Vermont Medical Center
Burlington Vermont, 05401, United States More Info
Contact
802-847-8400
Peter A Kaufman
Principal Investigator
Institut Jules Bordet
Brussel - Capital , 1070, Belgium More Info
Contact
003225413189
Philippe Aftimos
Principal Investigator
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium More Info
Contact
003216344634
Patrick Neven
Principal Investigator
Hôpital René Huguenin
Saint-Cloud Hauts-de-Seine, 92210, France
Universitätsklinikum Erlangen
Erlangen Bayern, 91054, Germany More Info
Peter A Fasching
Principal Investigator
Helios Kliniken Schwerin
Schwerin Mecklenburg-Vorpommern, 19049, Germany More Info
Nicole Stahl
Principal Investigator
Klinikum der Universitaet Muenchen
Muenchen , 80336, Germany More Info
Nadia Harbeck
Principal Investigator
Hospital Clinic I Provincial
Barcelona , 08036, Spain More Info
Contact
0034932275402
María Jesús Vidal Losada
Principal Investigator
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain More Info
Contact
0034915868115
Miguel Martin Jimenez
Principal Investigator
Hospital Madrid Norte Sanchinarro
Madrid , 28050, Spain More Info
Contact
0034917567984
Eva Ciruelos
Principal Investigator
The Royal Cornwall Hospital
Truro Cornwall, TR1 3, United Kingdom More Info
Duncan Wheatley
Principal Investigator
Barts Cancer Institute
London London City, EC1A , United Kingdom More Info
Peter Schmidt
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT04647487

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

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