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

NCT04582955 | Unknown

• 1 other identifier: CSIIT-C03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Objective Response Rate (ORR) by RECIST v1.1

  12 months

• pCR by other definitions

  12 months

• Breast conserving surgery rate

  12 months

• Event-free survival

  60 months

• Overall survival

  72 months

Study Arms (1)

Arm A

EXPERIMENTAL

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

Interventions

Chidamide in combination with chemotherapy 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

Also known as: Other Name: For Chidamide: HBI-8000, CS055

Arm A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 70, postmenopausal / premenopausal women;
• Patients with unilateral or bilateral primary invasive triple-negative (ER expression \< 1%, PR \< 1%, and HER2 negative \*) confirmed by histology or cytology;
• non-metastatic invasive TNBC（stage II-III）with at least one axillary lymph node involvement (T1cN1-2M0 or T2-3N1-2M0);
• previously untreated for breast cancer;
• There was at least one measurable primary lesion (according to RECIST v1.1);
• ECoG score 0-1;
• Adequate organ and marrow function as defined below:
• absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 100 × 109 / L, hemoglobin≥ 90 g / L;
• Volunteer to participate in this clinical trial and sign written informed consent

You may not qualify if:

• No measurable lesions, such as pleural or pericardial effusion, ascites, etc;
• 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);
• Previously treated with chemotherapy or HDAC inhibitors (including romidepsin, vorinostat, belinostat, and panobinostat，etc);
• Have allergic history to the components of this regimen;
• Treated with radiotherapy within 4 weeks before admission;
• Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
• Uncontrolled cardiovascular diseases, history of clinically significant QT interval prolongation, or QTc interval \> 450 ms at screening;
• 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);
• 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;
• 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;
• A clear history of epilepsy or dementia, including neurological disorders;
• The investigator determined not suitable to participate in this study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jin Zhang, professor

CONTACT

0086-22-2340 123; zhangjin@tjmuch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 12, 2020
• Study Start: October 30, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 7, 2020

Record last verified: 2020-11

Locations

CN (1)