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The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
Neoadjuvant Chemotherapy (NCT) is a standard treatment of patients who hope breast-conserving therapy (BCT) with locally advanced inoperable breast cancer or large tumor size. it is beneficial to degrading the tumor stage, increasing the rate of surgical resection or the BCT.People who are pathological complete response (pCR) after NCT have an improvement in disease-free survival (DFS) and overall survival (OS), as well as better prognosis. Currently, breast cancer are entering into the era of molecular classification. Different molecular subtype of breast cancer showed a significant difference in prognosis; triple negative breast cancer (TNBC) and Her2 positive breast cancer are clinically relevant terms referring to a specific subtype of breast cancer with high malignant characteristics, early recurrence and metastasis, but sensitive to primary chemotherapy, proportion of which are 15% and 20% respectively. A meta analysis shows that TNBC and her2 positive breast cancer have a higher pCR than Luminal A/B, and the increasing in pCR rate means improvement in survival.
The investigators previous study indicates that paclitaxel plus carboplatin with or without trastuzumab can improve pCR and prolong RFS in TNBC and her2 positive breast cancer Comparing to adjuvant chemotherapy.
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve(AUC4) d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year. RECIST is used once every 2 cycles. Patients will finish 6 cycles preoperative chemotherapy when CR/partial response(PR)/stable disease(SD) by RECIST without serious adverse events. |
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| postoperative chemotherapy | Active Comparator | Postoperative Chemotherapy:Standard chemotherapy regiments according to risk of recurrence: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH), EC/TC±H, and so on. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Chemotherapy | Drug | Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve(AUC4) d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pin Zhang, professor | Contact | 13701275563 | Zhang_pin@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Pin Zhang, professor | Chinese Academy of Medical Sciences (CAMS) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS) | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| postoperative chemotherapy | Drug | postoperative chemotherapy: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH), EC/TC±H, and so on. |
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| D017437 |
| Skin and Connective Tissue Diseases |