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This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.
All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch to CEF | Active Comparator | Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks. |
|
| Continue the neoadjuvant regimen | Experimental | Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. |
|
| Pathological complete response group with chemotherapy | Experimental | Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. |
|
| Pathological complete response group with no chemotherapy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Up to 5 years | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 4 months during adjuvant therapy | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsong Lu, MD | Contact | lujjss@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University School of Medicine, Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| Cisplatin | Drug |
|
| Epirubicin | Drug |
|
| Cyclophosphamide | Drug |
|
| 5-fluoruracil | Drug |
|
|
| regional recurrence free survival (RRFS) |
| 5 years |
| local recurrence free survival (LRFS) | 5 years |
| distant-disease- free survival (DDFS) | 5 years |
| ID | Term |
|---|---|
| D018270 | Carcinoma, Ductal, Breast |
| D058922 | Inflammatory Breast Neoplasms |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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