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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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) |
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Inclusion Criteria:
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
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Zhang, professor | Contact | 0086-22-2340 123 | 2121 | zhangjin@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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 |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |