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

Chidamide Combined With Neoadjuvant Chemotherapy in Early Triple-negative Breast Cancer

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

Study Overview

• Status: Unknown
• Conditions: Triple-negative Breast Cancer
• Intervention / Treatment: Drug: Chidamide in combination with chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Hospital
      • Contact: Jin Zhang, M.D,Ph.D; Phone Number: 2121 0086-22-2340 123; Email: zhangjin@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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; Other Names: Other Name: For Chidamide: HBI-8000, CS055

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Outcome: pathologic complete response（pCR） rate（ypT0/is ypN0）	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	1years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: neoadjuvant; triple-negative breast cancer; Chidamide
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: CSIIT-C03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No