NCT04465097

Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-08
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2020-07-09
• Last updated: 2023-10-17

Locations

1 site across 1 country: China