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A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT02107703
Protocol IDs
15362 (primary)
I3Y-MC-JPBL
2013-004728-13
Study Sponsor
Eli Lilly and Company

Summary

The main purpose of this study is to compare progression-free survival for women with hormone
receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced
breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants
will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9
months for each participant.

For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

Eligibility

  1. Have a diagnosis of HR+, HER2- breast cancer
  2. Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:
  3. relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
  4. relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
  5. relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
  6. presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
  7. for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
  8. Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
  9. Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
  10. Have either measurable disease or nonmeasurable bone only disease
  11. Have a performance status =1 on the Eastern Cooperative Oncology Group (ECOG) scale
  12. Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy

Treatment Sites in Georgia

Harbin Clinic Cancer Center


255 West Fifth Street
Rome, GA 30165
706-528-9110
www.harbinclinic.com

Study Coordinator:
Terri Brannon
706-528-9094

Doctors:

Dilawar Khan MD

University Cancer and Blood Center, LLC - Athens Medical Oncology


3320 Old Jefferson Road
Building 700
Athens, GA 30607
706-353-2990 x279
www.universitycancer.com

**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.
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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.