Clinical trial NCT04582955: Neoadjuvant Treatment of Early Triple-negative Breast Cancer With Chidamide and Chemotherapy
Official title: Chidamide Combined With Neoadjuvant Chemotherapy in Early Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Triple-negative Breast Cancer
Keywords: neoadjuvant
Chidamide
triple-negative breast cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Efficacy Outcome: pathologic complete response（pCR） rate（ypT0/is ypN0）
timeFrame: 1years
Secondary outcomes:
measure: Objective Response Rate (ORR) by RECIST v1.1
timeFrame: 12 months
measure: pCR by other definitions
timeFrame: 12 months
measure: Breast conserving surgery rate
timeFrame: 12 months
measure: Event-free survival
timeFrame: 60 months
measure: Overall survival
timeFrame: 72 months
measure: Incidence of Adverse Events (AEs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
References: