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The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.
The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT | Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles | ||
| AT-NP | docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response rate | one year |
| Measure | Description | Time Frame |
|---|---|---|
| clinical response rate, safety | one year |
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Inclusion Criteria:
Diagnosis of invasive ductal or lobular breast cancer.
Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)
Performance Status ECOG <2
Age > 18 years
Tumor > 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky >50%
Lab test :
Absolute neutrophil count > 1,500/mm3
serum creatinine ≤ 1.5×ULN
Exclusion Criteria:
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diaganosis of invasive breast cancer, tumor size > 2.0cm by MRI or ultrasound or clinical examination.
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| Name | Affiliation | Role |
|---|---|---|
| Zefei Jiang, MD | Hospital Affiliated Military Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital affiliated academy military medical science | Recruiting | Beijing | Beijing Municipality | 100071 | 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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| D017437 |
| Skin and Connective Tissue Diseases |