Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Tucidinostat; Drug: Exemestane; Drug: Ovarian function suppression

• Registration Number: NCT04465097
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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 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.

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-07
• Study Start: 2020-07-08
• Study First Posted: 2020-07-09
• Status Verified: 2023-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-15
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tucidinostat and Exemestane	Tucidinostat	Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.
Tucidinostat and Exemestane	Exemestane	Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.
Tucidinostat and Exemestane	Ovarian function suppression	Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.

Primary Outcome Measures

Name	Time	Method
objective response rate (ORR) evaluated by MRI	Up to 31 weeks	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The first affiliated hospital of Sun Yat-Sen university; 🇨🇳 Guangzhou, Guangdong, China