This trial is testing the side effects and best dose of two drugs, abemaciclib and niraparib, to treat patients with hormone receptor positive breast cancer that is negative for HER2. Abemaciclib works by blocking proteins that are needed for cell growth, and niraparib inhibits a protein that helps repair DNA mutations. The combination of these two drugs may make the tumor smaller before surgery.
- Hormone Receptor-positive Breast Cancer
- Breast Cancer
- Stage 2 Breast Cancer
- Stage IA Breast Cancer
- Stage IIA Breast Cancer
- Stage IB Breast Cancer
- Stage II Breast Cancer
- Stage IIB Breast Cancer
- Unilateral Breast Cancer
- Stage 1 Breast Cancer
- Stage IIIA Breast Cancer
- Multifocal Breast Cancer
- Stage IIIB Breast Cancer
- HER2-negative Breast Cancer
2 Primary · 5 Secondary · Reporting Duration: Up to 5 years from the last dose of study drugs
Side Effects for
Awards & Highlights
1 Treatment Group
Treatment (abemaciclib, niraparib)
1 of 1
8 Total Participants · 1 Treatment Group
Primary Treatment: Abemaciclib · No Placebo Group · Phase 1
Who is running the clinical trial?
Age 18+ · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
How many participants are enrolled in this research study?
"Affirmative. According to records found on clinicaltrials.gov, this trial is still in search of 25 individuals from 1 centre. It was first made public on June 7th 2021 and its details were revised for the last time on July 29th 2022." - Anonymous Online Contributor
To what degree is Abemaciclib considered to be a secure medical treatment for patients?
"There is a limited amount of data regarding Abemaciclib's safety and efficacy, so it received the lowest score of 1." - Anonymous Online Contributor
What are the desired outcomes of this clinical experiment?
"Eli Lilly and Company, the clinical trial sponsor, reports that its primary outcome is the incidence of dose-limiting toxicities (DLTs) over a period up to 90 days after receiving the final dosage. Additionally, secondary outcomes such as rate of residual cancer burden (RCB), delay in breast surgery attributed to treatment-related toxicity, and pathological complete response (pCR) will be tabulated proportionally and analyzed descriptively." - Anonymous Online Contributor
Are there any precedent investigations involving Abemaciclib?
"Presently, 189 clinical trials involving Abemaciclib are in progress. 29 of these active studies have advanced to Phase 3. Although most of the research is based out of Washington D.C., 7797 locations across the country are running related studies for this drug." - Anonymous Online Contributor
In what cases is Abemaciclib usually prescribed?
"Abemaciclib is a viable therapeutic option for those suffering from disease, high risk of recurrence, and primary peritoneal cancer." - Anonymous Online Contributor
Is this endeavor a pioneering effort in its field?
"Since its inception in 2009, Eli Lilly and Company has conducted a total of 48 studies on Abemaciclib. Currently active trials are being held across 1482 cities in 52 different countries. The initial trial was composed of 220 patients and achieved Phase 1 drug approval status." - Anonymous Online Contributor
Is the enrollment process still open for this experiment?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this investigation, initially posted in June of 2021, is actively trying to recruit patients. 25 volunteers must be sourced from a single medical centre." - Anonymous Online Contributor