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

NCT ID: NCT04582955

Last Updated: 2020-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2022-12-31

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

Conditions

Triple-negative Breast Cancer

Keywords

neoadjuvant; Chidamide; triple-negative breast cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: EXPERIMENTAL

Chidamide in combination with chemotherapy

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Other Name: For Chidamide: HBI-8000, CS055

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jin Zhang, professor

Role: CONTACT

Phone: 0086-22-2340 123

Email: zhangjin@tjmuch.com

Facility Contacts

Jin Zhang, M.D,Ph.D

Role: primary

Other Identifiers

CSIIT-C03

Identifier Type: -

Identifier Source: org_study_id