Study Summary
This trial looks at the safety of using abemaciclib in different combinations of drugs to treat breast cancer that has spread.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Baseline to study completion (estimated as 12 months)
Trial Safety
Safety Progress
Trial Design
13 Treatment Groups
LY3023414 + LY2835219 + Fulvestrant Dose Escalation
1 of 13
LY2835219+ Trastuzumab Dose Expansion
1 of 13
LY2835219 + Exemestane
1 of 13
LY3023414 + LY2835219 + Fulvestrant Dose Expansion
1 of 13
LY2835219 + Letrozole
1 of 13
LY2835219 + Exemestane + Everolimus Dose Escalation
1 of 13
LY2835219 + Tamoxifen
1 of 13
LY2835219 + Exemestane + Everolimus Dose Expansion
1 of 13
LY2835219 + Anastrozole
1 of 13
LY2835219 + Endocrine Therapy
1 of 13
LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose Escalation
1 of 13
LY2835219+ Trastuzumab Dose Escalation
1 of 13
LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose Expansion
1 of 13
Experimental Treatment
198 Total Participants · 13 Treatment Groups
Primary Treatment: Endocrine therapy · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 18 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Gelbert, Lawrence M., Shufen Cai, Xi Lin, Concepcion Sanchez-Martinez, Miriam del Prado, Maria Jose Lallena, Raquel Torres, et al.. 2014. “Preclinical Characterization of the CDK4/6 Inhibitor LY2835219: In-vivo Cell Cycle-dependent/independent Anti-tumor Activities Alone/in Combination with Gemcitabine”. Investigational New Drugs. Springer Science and Business Media LLC. doi:10.1007/s10637-014-0120-7.
- Tolaney, Sara M., Muralidhar Beeram, J. Thaddeus Beck, Alison Conlin, E. Claire Dees, Shannon L. Puhalla, Brent N. Rexer, et al.. 2022. “Abemaciclib in Combination with Endocrine Therapy for Patients with Hormone Receptor-positive, Her2-negative Metastatic Breast Cancer: A Phase 1b Study”. Frontiers in Oncology. Frontiers Media SA. doi:10.3389/fonc.2021.810023.
- 2014. "A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02057133.
Frequently Asked Questions
What medical conditions are Endocrine therapies most often prescribed for?
"Endocrine therapy, which is used to target estrogen receptors, has the potential to combat a range of illnesses such as disease progression, diarrhea, and pulmonary issues." - Anonymous Online Contributor
Are there vacancies currently available for participants of this research?
"At present, this trial is not open for enrollment. The study was first made available on March 10th 2014 and last updated August 8th 2022; however, if you are looking for other clinical trials there are 2287 studies focusing on breast cancer that are still accepting patients and 613 endocrine therapy related experiments." - Anonymous Online Contributor
Have any prior experiments been conducted related to Endocrine treatment?
"Endocrine therapy was initially examined in 1994 at Queen Mary University of London. Since then, a total of 1272 trials have been finished, and 613 are presently active - notably there is a high concentration of research conducted out of Nashville, Tennessee." - Anonymous Online Contributor
At which locations is this research experiment being conducted?
"Patients in need of this medical intervention can be enrolled at Tennessee Oncology PLLC, Providence Cancer Center Oncology Hematology Care and University of North Carolina at Chapel Hill. Additionally, there are 16 other enrolment sites across the United States." - Anonymous Online Contributor
Has Endocrine therapy received authorization from the FDA yet?
"We gave endocrine therapy a score of 1 on our scale, indicating that while it has been trialled before, there is limited evidence to support its efficacy and safety." - Anonymous Online Contributor
To what extent is this experiment being conducted with participants?
"At this time, no patients are being enrolled in the trial. The study was initially released on March 10th 2014 and has since been updated as recently as August 8th 2022. However, if you wish to explore alternative options for participation there are currently 2287 studies actively seeking out individuals with breast cancer and 613 endocrine therapy trials looking for participants." - Anonymous Online Contributor