A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | June 10, 2014 |
End Date: | October 22, 2018 |
A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
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.
effective in treating participants with breast cancer who have already tried other drug
treatments.
Inclusion Criteria.
- 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.
Exclusion Criteria:
- 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).
We found this trial at
28
sites
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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