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This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: TCHP | Experimental | docetaxel/carboplatin/trastuzumab/Pertuzumab |
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| Arm B: EC-THP | Active Comparator | epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCHP | Drug | Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations. |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | pathologic complete response | one year |
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Inclusion Criteria:
• Histologically or cytologically confirmed HER2 positive invasive breast carcinoma
Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3 Total bilirubin < upper limit of normal Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility
Exclusion Criteria:
• Metastatic disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kung Wang, MD | Contact | : 00862083827812 | 50910 | gzwangkun@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Recruiting | Guangzhou | China |
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