Trials / Unknown
UnknownNCT05191914
Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors
Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to Cyclin-dependent Kinases（CDK）4/6 Inhibitors
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Liaoning Cancer Hospital & Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The trial used a multicenter, open, single-arm design in which patients were treated with Chidamide combined with Fulvestrant.The primary objective is to evaluate the preliminary efficacy and safety of Chidamide in combination with Fulvestrant.Patients included in the trial were advanced breast cancer progressing on first-line aromatase inhibitor + Cyclin-dependent kinases（CDK）4/6i rescue therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Chidamide+ Fulvestrant | Drug: Chidamide chidamide 30mg orally，Biw Drug: Fulvestrant Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 |
Timeline
- Start date
- 2022-02-07
- Primary completion
- 2022-07-30
- Completion
- 2022-12-30
- First posted
- 2022-01-14
- Last updated
- 2022-01-14
Source: ClinicalTrials.gov record NCT05191914. Inclusion in this directory is not an endorsement.