Trials / Recruiting
RecruitingNCT05524584
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.
Conditions
- Breast Cancer
- Metastatic Breast Cancer
- Hormone Receptor-positive Breast Cancer
- HER2-negative Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fulvestrant | Given intramuscularly |
| DRUG | Anastrozole | Given orally |
| DRUG | Abemaciclib | Given orally |
Timeline
- Start date
- 2022-08-31
- Primary completion
- 2028-12-31
- Completion
- 2031-12-31
- First posted
- 2022-09-01
- Last updated
- 2026-03-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05524584. Inclusion in this directory is not an endorsement.