Status:
COMPLETED
Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 c...
Detailed Description
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. ...
Eligibility Criteria
Inclusion
- Written informed consent must be signed；
- Eastern Cooperative Oncology Group Performance Status: 0\~1;
- Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer;
- Age ≥18 years old；
- No distant metastatic disease；
- The disease condition is stage II or stage III;
- Laboratory exam criteria for enrollment: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2 times ULN, TBIL, CCr≤1.5 times ULN.
Exclusion
- Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation).
- Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ
- Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
- Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes.
- Patients who had myocardial infarction in the past 12 months.
- Patients who participate in other clinical trail.
- Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04465097
Start Date
July 8 2020
End Date
October 1 2023
Last Update
October 17 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The first affiliated hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China, 510000