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Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

Official Title

A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer Endocrine Therapy, Taxane, MONARCH 1 Breast Neoplasms

Eligibility

You can join if…

Open to females ages 18 years and up

.

  • Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
  • Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
  • Prior treatment with at least 2 chemotherapy regimens:
  • At least 1 of these regimens must have been administered in the metastatic setting.
  • At least 1 of these regimens must have contained a taxane.
  • No more than 2 prior chemotherapy regimens in the metastatic setting.
  • Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
  • Have discontinued all previous therapies for cancer.
  • Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.

You CAN'T join if...

  • Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
  • Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6)inhibitor.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
  • Have had major surgery within 14 days of the initial dose of study drug.
  • Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

Locations

  • Univ of California San Francisco
    San Francisco, California, 94115, United States
  • Sansum Medical Research Foundation
    Santa Barbara, California, 93105, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT02102490
Phase
Phase 2
Study Type
Interventional
Last Updated
October 27, 2017