Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    First Affiliated Hospital, Sun Yat-Sen University
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Updated on 5 August 2020
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cancer
estrogen
breast cancer
metastasis
estrogen receptor
invasive breast cancer
exemestane
tucidinostat

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.

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. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.

Details
Condition Breast Cancer, Breast Cancer
Age 18years - 100years
Treatment Tucidinostat, Exemestane, Ovarian function suppression
Clinical Study IdentifierNCT04465097
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

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: HGB10g/dl, WBC4,000/mm3, PLT100,000/mm3, GOT, GPT, ALP2 times ULN, TBIL, CCr1.5 times ULN

Exclusion Criteria

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
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