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This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxorubicin/cyclophosphamide | Experimental | Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Chemotherapy with Docetaxel | Drug | Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response. | 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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