Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

Breast Cancer Clinical Trial

— NeoTEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465097
• Other study ID #: 20200628GD
• Status: Completed
• Phase: Phase 2
• Start date: July 8, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent must be signed;

2. Eastern Cooperative Oncology Group Performance Status: 0~1;

3. Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer;

4. Age =18 years old;

5. No distant metastatic disease;

6. The disease condition is stage II or stage III;

7. 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 Criteria:

1. Patients who are pregnant or lactating at the time of randomization or refuse to contraception.

2. Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation).

3. Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ

4. 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.

5. Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes.

6. Patients who had myocardial infarction in the past 12 months.

7. Patients who participate in other clinical trail.

8. Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tucidinostat
Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26
• Exemestane
Exemestane: 25 mg QD from week 1 to week 26.
• Ovarian function suppression
If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.

Locations

Country	Name	City	State
China	The first affiliated hospital of Sun Yat-Sen university	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Jiang Z, Li W, Hu X, Zhang Q, Sun T, Cui S, Wang S, Ouyang Q, Yin Y, Geng C, Tong Z, Cheng Y, Pan Y, Sun Y, Wang H, Ouyang T, Gu K, Feng J, Wang X, Wang S, Liu T, Gao J, Cristofanilli M, Ning Z, Lu X. Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):806-815. doi: 10.1016/S1470-2045(19)30164-0. Epub 2019 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 31 weeks
Secondary	objective response rate (ORR) evaluated by CEUS	Contrast-enhanced ultrasound will also be performed to assess ORR	Up to 31 weeks
Secondary	pathologic complete response rate (pCR)	The percentage of participants with pathologically assessed ypT0 and ypTis of breast disease.	Up to 31 weeks
Secondary	Adverse effect (AE)	All advese effect events related with Tucidinostat and Exemestane.	Up to 31 weeks
Secondary	Residual Cancer Burden (RCB)	Pathologilly assessed residual cancer burden according to MD Anderson protocol.	Up to 31 weeks