Trials / Terminated
TerminatedNCT04305236
Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer
A Phase II Open Label Trial of Neo-Adjuvant Abemaciclib With Fulvestrant in Patients Who Develop Localized Recurrence While on Adjuvant Endocrine Therapy With Molecular Evidence of Endocrine Resistance
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2 single-arm, open-label determining efficacy of Neo-adjuvant Abemaciclib and Fulvestrant in subjects with Hormone receptor positive patients with localized non-metastatic breast cancer who develop local recurrence while on adjuvant endocrine therapy with molecular evidence of endocrine resistance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abemaciclib | Given PO |
| DRUG | Fulvestrant | Given Intramuscularly |
Timeline
- Start date
- 2020-07-23
- Primary completion
- 2022-02-16
- Completion
- 2022-02-16
- First posted
- 2020-03-12
- Last updated
- 2023-06-06
- Results posted
- 2023-03-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04305236. Inclusion in this directory is not an endorsement.