Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

NCT04465097 | Completed Phase 2

• 1 other identifier: 20200628GD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Tucidinostat; Estrogen Receptor-Positive; Neoadjuvant endocrine therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• objective response rate (ORR) evaluated by CEUS

  Up to 31 weeks

• pathologic complete response rate (pCR)

  Up to 31 weeks

• Adverse effect (AE)

  Up to 31 weeks

• Residual Cancer Burden (RCB)

  Up to 31 weeks

Study Arms (1)

Tucidinostat and Exemestane

EXPERIMENTAL

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.

Drug: Tucidinostat; Drug: Exemestane; Drug: Ovarian function suppression

Interventions

Tucidinostat DRUG

Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26

Also known as: Chidamide, Epidaza

Tucidinostat and Exemestane

Exemestane DRUG

Exemestane: 25 mg QD from week 1 to week 26.

Tucidinostat and Exemestane

Ovarian function suppression DRUG

If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.

Tucidinostat and Exemestane

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2 times ULN, TBIL, CCr≤1.5 times ULN.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The first affiliated hospital of Sun Yat-Sen university

Guangzhou, Guangdong, 510000, China

Location

Related 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.

  PMID: 31036468 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ying Lin, MD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Department of Breast Surgery

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 9, 2020
• Study Start: July 8, 2020
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)