A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer That Has Spread to the Brain
Conditions
Breast Cancer - Brain Metastases
Conditions: official terms
Brain Neoplasms - Breast Neoplasms - Neoplasm Metastasis
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Abemaciclib
Type: Drug
Overall Status
Recruiting
Summary
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer that has spread to the brain.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Women with brain metastases secondary to hormone receptor positive breast cancer.

- Have either human epidermal growth factor receptor 2 positive (HER2+) disease (Study Part A) or HER2- disease (Study Part B). Participants in Study Part C may have either HER2+ or HER2- disease, and must have brain lesions clinically indicated for surgical resection as well as provide consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.

- For Parts A & B: Must have at least 1 new or not previously irradiated measurable metastatic brain lesion ≥10 millimeters (mm) in the longest diameter (LD) or a progressive previously irradiated metastatic brain lesion on radiographic imaging by gadolinium-enhanced magnetic resonance imaging (Gd MRI). Note: for participants with prior whole brain radiotherapy (WBRT) or stereotactic radiosurgery (SRS), previously irradiated lesion(s) must demonstrate unequivocal progression on baseline Gd-MRI in the opinion of the investigator. Otherwise new or not previously irradiated lesions must be present. For Part C (surgical): Have 1 to 3 metastatic brain lesion(s) for which surgical resection is clinically indicated.

- Have completed local therapy (surgical resection, WBRT, or SRS) ≥14 days prior to initiating abemaciclib and recovered from all acute effects. Participants are not required to have received prior local therapy for study participation.

- If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.

- Have a Karnofsky performance status of ≥70.

- Have a life expectancy ≥12 weeks.

- If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and intracranial disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.

- Have discontinued all previous therapies for cancer (including cytotoxic chemotherapy, targeted therapy [including, but not limited to, everolimus], radiotherapy, immunotherapy, and investigational therapy) for at least 14 days prior to receiving abemaciclib and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia or peripheral neuropathy. Note: participants currently receiving trastuzumab and receiving clinical benefit may continue to receive trastuzumab throughout the study. Concurrent treatment with trastuzumab emtansine (T-DM1) is not allowed.

- Have adequate organ function.

Exclusion Criteria:

- Require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.

- Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).

- Have evidence of significant (ie, symptomatic) intracranial hemorrhage.

- Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.

- Have experienced >2 seizures within 4 weeks prior to study entry.

- Have previously received treatment with any cyclin dependent kinases 4/6 (CDK4/6) inhibitor.

- Have known contraindication to Gd-MRI.

- Are currently receiving lapatinib.

- Have a preexisting chronic condition resulting in persistent diarrhea.
Locations
University of California - San Diego
La Jolla, California, United States
Status: Not yet recruiting
Contact: - 858-822-7778
Univ of California San Francisco
San Francisco, California, United States
Status: Not yet recruiting
Contact: - 415-885-3732
University of Colorado Cancer Center
Aurora, Colorado, United States
Status: Recruiting
Contact: - 720-848-1030
Florida Cancer Specialists
Fort Myers, Florida, United States
Status: Recruiting
Contact: - 239-275-6400
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Status: Recruiting
Contact: - 813-745-3871
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: - 617-632-3800
University of Michigan
Ann Arbor, Michigan, United States
Status: Not yet recruiting
Contact: - 734-764-1817
Washington University Medical Center
Saint Louis, Missouri, United States
Status: Recruiting
Contact: - 314-399-6827
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Not yet recruiting
Contact: - 212-639-5875
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: - 919-966-4431
Providence Health and Services
Portland, Oregon, United States
Status: Not yet recruiting
Contact: - 506-216-8636
University of Pittsburgh School of Medicine
Pittsburg, Pennsylvania, United States
Status: Not yet recruiting
Contact: - 412-641-3494
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Status: Recruiting
Contact: - 615-329-7274
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Status: Recruiting
Contact: - 615-340-2827
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wien, Austria
Status: Recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brussel, Belgium
Status: Recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Charleroi, Belgium
Status: Recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leuven, Belgium
Status: Recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montreal, Canada
Status: Not yet recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottawa, Canada
Status: Not yet recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lille Cedex, France
Status: Recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lyon Cedex 08, France
Status: Recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris Cedex 05, France
Status: Recruiting
Contact: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toulouse cedex 9, France
Status: Recruiting
Contact: Eli Lilly and Company
Start Date
April 2015
Completion Date
December 2017
Sponsors
Eli Lilly and Company
Source
Eli Lilly and Company
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page