Neoadjuvant Treatment of Early Triple-negative Breast Cancer With Chidamide and Chemotherapy

Not Applicable

• Conditions: Triple-negative Breast Cancer
• Interventions: Drug: Chidamide in combination with chemotherapy

• Registration Number: NCT04582955
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

Objective to evaluate the efficacy and safety of neoadjuvant therapy with Chidamide combined with chemotherapy for stage II - III triple-negative breast cancer，and to compare the efficacy and safety of chemotherapy with Chidamide and chemotherapy alone in the neoadjuvant treatment of stage II - III triple-negative breast cancer

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-12
• Study Start: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Age ≥ 18 and ≤ 70, postmenopausal / premenopausal women;

2. Patients with unilateral or bilateral primary invasive triple-negative (ER expression < 1%, PR < 1%, and HER2 negative *) confirmed by histology or cytology;

3. non-metastatic invasive TNBC（stage II-III）with at least one axillary lymph node involvement (T1cN1-2M0 or T2-3N1-2M0);

4. previously untreated for breast cancer;

5. There was at least one measurable primary lesion (according to RECIST v1.1);

6. ECoG score 0-1;

7. Adequate organ and marrow function as defined below:

   absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 100 × 109 / L, hemoglobin≥ 90 g / L;

8. Volunteer to participate in this clinical trial and sign written informed consent

Exclusion Criteria

1. No measurable lesions, such as pleural or pericardial effusion, ascites, etc;
2. Major surgical procedures or significant trauma were performed within 4 weeks before enrollment, or patients were expected to receive major surgical treatment (not related to breast cancer);
3. Previously treated with chemotherapy or HDAC inhibitors (including romidepsin, vorinostat, belinostat, and panobinostat，etc);
4. Have allergic history to the components of this regimen;
5. Treated with radiotherapy within 4 weeks before admission;
6. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
7. Uncontrolled cardiovascular diseases, history of clinically significant QT interval prolongation, or QTc interval > 450 ms at screening;
8. Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT / AST > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value);
9. Pregnant, lactating or fertile women with a positive baseline pregnancy test; or subjects of childbearing age who are not willing to take effective contraceptive measures during the study period and at least 8 weeks after the last administration;
10. According to the judgment of the investigator, there are some concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect patients to complete the study;
11. A clear history of epilepsy or dementia, including neurological disorders;
12. The investigator determined not suitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Chidamide in combination with chemotherapy	Chidamide, orally,20mg at day 0,4,7,11,21,every 3 weeks; in combination with Docetaxel 75mg/m2,intravenous infusion，at day1 every 3 weeks，and Epirubicin 75mg/m2, intravenous infusion，at day1 every 3 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome: pathologic complete response（pCR） rate（ypT0/is ypN0）	1years	pCR defined as no invasive tumour residuals in breast and no invasive and no non-invasive tumour residuals in axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) by RECIST v1.1	12 months	Objective Response Rate (ORR) by RECIST v1.1
Event-free survival	60 months	Event-free survival
Breast conserving surgery rate	12 months	Breast conserving surgery rate
Incidence of Adverse Events (AEs)	12 months	Incidence of Adverse Events (AEs)
pCR by other definitions	12 months	response by other pCR definitions（ypT0 ypN0; ypT0 ypN0/+;ypT0/is ypN0/+; ypT\[any\] ypN0）
Overall survival	72 months	Overall survival

Trial Locations

Locations (1)

Tianjin Medical University Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China