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This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
It is know that triple-negative breast cancer(TNBC) is more aggressive than non-triple negative breast cancer in both pathological features and clinical prognosis,and there is no standard chemotherapy regimens especially for TNBC. NCCN guidelines recommends Paclitaxel or Epirubicin based regimens as the preferred regimens both for the adjuvant chemotherapy and the treatment of Recurrence and Metastatic breast cancer.The combination of these two drugs is considered as a strong arrangement and therefore,is common used in Triple negative breast cancer patients because of its poor prognosis.
According to the results of some retrospective studies, platinum-based chemotherapy regimens showed a promising sensitive to Triple negative breast cancer patients compared with regimens without platinum.
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET | Active Comparator | The control arm receive the paclitaxel plus epirubicin |
|
| PC | Experimental | the experimental arm which receive the paclitaxel combined with carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel plus carboplatin | Drug | Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v. 1 cycle = 21days 2-6cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery | After patients complete the neoadjuvant chemothreapy and receive the surguries,we can get their pathology ,and compare the pCR(pathological complete remission)rates of two amrs | One week after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| follow-up the patient every 3-6 months to obtain the 3 year-DFS(disease free survival ) and OS(overall survival ) | we follow up the patients every 6 month ,up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHANG Pin, BD | Contact | +861087788120 | zhang_pin@sina.com | |
| YIN Yi, BD | Contact | elovf1@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ZHANG Pin, BD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer institute &Hospital,Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | 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 |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel and epirubicin | Drug | Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1,2 i.v. 1 cycle = 21days 2-6cycles |
|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |