Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer
NCT04465097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-10-17
Summary
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.
Conditions
Interventions
- DRUG
-
Tucidinostat
Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26
- DRUG
-
Exemestane
Exemestane: 25 mg QD from week 1 to week 26.
- DRUG
-
Ovarian function suppression
If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.
Sponsors & Collaborators
-
First Affiliated Hospital, Sun Yat-Sen University
lead OTHER
Principal Investigators
-
Ying Lin, MD · First Affiliated Hospital, Sun Yat-Sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-08
- Primary Completion
- 2023-10-01
- Completion
- 2023-10-01
Countries
- China
Study Locations
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