A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:September 14, 2016
End Date:December 20, 2019

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A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus
tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive
(HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.


Inclusion Criteria:

- Have a diagnosis of HR+, HER2- breast cancer.

- Relapsed or progressed following endocrine therapy.

- Have received prior treatment with at least 2 chemotherapy regimens, of which at least
1 but no more than 2 have been administered in the metastatic setting.

- Have the presence of measureable disease as defined by the Response Evaluation
Criteria in Solid Tumors (RECIST 1.1).

- Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.

- 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.

- Have adequate organ function.

- Have negative serum pregnancy test within 7 days prior to the first dose of study
treatment and agree to use highly effective precautions to prevent pregnancy during
the study and for 12 weeks following last dose of study treatment.

- Are able to swallow oral medication.

Exclusion Criteria:

- Have clinical evidence or history of central nervous system metastasis.

- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days prior to randomization of study drug for a
nonmyelosuppressive or myelosuppressive agent, respectively.

- Have had major surgery within 14 days prior to randomization of study drug to allow
for post-operative healing of the surgical wound and site(s).

- Have a personal history of any of the following conditions: syncope of either
unexplained or cardiovascular etiology, ventricular tachycardia, ventricular
fibrillation, or sudden cardiac arrest.

- Have active bacterial or fungal infection (that is, requiring intravenous antibiotics
at the time of initiating study treatment) and/or detectable viral infection.

- Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6
inhibitor.

- Have a preexisting chronic condition resulting in persistent diarrhea.

- Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma
in-situ of the cervix or breast), unless in complete remission with no therapy for a
minimum of 3 years.
We found this trial at
7
sites
Fort Worth, Texas 76104
Principal Investigator: Robyn Young
Phone: 817-759-7000
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Caba,
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Peter Kaufman
Phone: 603-650-7854
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Madison, Wisconsin 53705
Principal Investigator: Kari Wisinski
Phone: 608-262-2876
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Madison, WI
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
Sarah Cannon Cancer Center People who live with cancer
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Erika Hamilton
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Tucson, Arizona
Principal Investigator: Pavani Chalasani
Phone: 520-626-0191
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Tucson, AZ
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