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Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Status
Closed
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05169567
Protocol IDs
18238 (primary)
NCI-2022-05155
2021-002301-10
I3Y-MC-JPEF
Study Sponsor
Eli Lilly and Company

Summary

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of
hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)
breast cancer that progressed or recurred after previous treatment with a type of drug known
as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years,
depending on how you and your tumor respond.

Eligibility

  1. Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
  2. Have radiologic evidence of disease progression or recurrence either
  3. On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
  4. On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
  5. Must be deemed appropriate for treatment with ET
  6. If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
  7. Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
  8. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
  9. Have adequate renal, hematologic, and hepatic organ function
  10. Must be able to swallow capsules/tablets

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.