Trials / Unknown
UnknownNCT04999540
Tucidinostat and Fulvestrant in Hormone-receptor Positive Advanced Breast Cancer
Trial of Tucidinostat in Combination With Fulvestrant in Patients With Hormone-receptor Positive Advanced Breast Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- Sponsor
- Guangdong Women and Children Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is evaluate the efficacy and safety of tucidinostat in combination with fulvestrant in patients with hormone-receptor positive advanced breast cancer.
Detailed description
Hormone-receptor positive breast cancer is the most common subtype in breast cancer. Tucidinostat is an oral subtype-selective histone deacetylase inhibitor, which showed preliminary signs of encouraging anti-tumour activity in patients with advanced hormone-receptor positive breast cancer in the previous studies. The aim of this study is to evaluate the efficacy and safety of Tucidinostat in combination with fulvestrant in patients with recurrent or metastatic hormone-receptor positive breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tucidinostat | 30 mg, administered orally twice per week (BIW) |
| DRUG | Fulvestrant | Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml. |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2023-12-01
- Completion
- 2024-12-30
- First posted
- 2021-08-11
- Last updated
- 2021-08-11
Source: ClinicalTrials.gov record NCT04999540. Inclusion in this directory is not an endorsement.