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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26
Exemestane: 25 mg QD from week 1 to week 26.
If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.
The first affiliated hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China
objective response rate (ORR) evaluated by MRI
ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators using MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 31 weeks
objective response rate (ORR) evaluated by CEUS
Contrast-enhanced ultrasound will also be performed to assess ORR
Time frame: Up to 31 weeks
pathologic complete response rate (pCR)
The percentage of participants with pathologically assessed ypT0 and ypTis of breast disease.
Time frame: Up to 31 weeks
Adverse effect (AE)
All advese effect events related with Tucidinostat and Exemestane.
Time frame: Up to 31 weeks
Residual Cancer Burden (RCB)
Pathologilly assessed residual cancer burden according to MD Anderson protocol.
Time frame: Up to 31 weeks
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