Clinical trial NCT04465097: Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer
Official title: Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Tucidinostat
Estrogen Receptor-Positive
Neoadjuvant endocrine therapy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: objective response rate (ORR) evaluated by MRI
timeFrame: Up to 31 weeks
Secondary outcomes:
measure: objective response rate (ORR) evaluated by CEUS
timeFrame: Up to 31 weeks
measure: pathologic complete response rate (pCR)
timeFrame: Up to 31 weeks
measure: Adverse effect (AE)
timeFrame: Up to 31 weeks
measure: Residual Cancer Burden (RCB)
timeFrame: Up to 31 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Sun Yat-Sen university
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ying Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.