Overview

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

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
Female
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
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Criteria
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.