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To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes
EC-T regimen: epirubicin 90mg/m2 day1, CTX 600mg/m2, day 1, 21 days per cycle *4cycle. followed by paclitaxel 175mg/m2,d1,21days per cycle, 4 cycle.
ET regimen: epirubicin 75mg/m2 day1,paclitaxel 175mg/m2,d2,21days per cycle, 6 cycle
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: EC-T regimen | Active Comparator |
| |
| Group B: ET regimen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin, CTX, Paclitaxel | Drug | Epirubicin 90mg/m2 and CTX 600mg/m2 on day1 of each 21-day cycle, 4 cycles; followed by Paclitaxel 175mg/m2 on day1 of each 21-day cycle, 4 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | 5 years after all the recuiment |
| Measure | Description | Time Frame |
|---|---|---|
| OS | 5 years after all the adjuvent treatments | |
| Safety | Assessing for Hematology and Non-hematology toxicities, including all SAEs. | 5 years after all the recruiment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Yuan, M.D. | Contact | 86-10-8778 8114 | yuanpeng01@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Binghe Xu, M.D. | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute & Hospital. Chinese Academy of Medical Sciences | Recruiting | Beijing | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20458045 | Background | Moebus V, Jackisch C, Lueck HJ, du Bois A, Thomssen C, Kurbacher C, Kuhn W, Nitz U, Schneeweiss A, Huober J, Harbeck N, von Minckwitz G, Runnebaum IB, Hinke A, Kreienberg R, Konecny GE, Untch M. Intense dose-dense sequential chemotherapy with epirubicin, paclitaxel, and cyclophosphamide compared with conventionally scheduled chemotherapy in high-risk primary breast cancer: mature results of an AGO phase III study. J Clin Oncol. 2010 Jun 10;28(17):2874-80. doi: 10.1200/JCO.2009.24.7643. Epub 2010 May 10. | |
| Background | Intense Dose-Dense Sequential Chemotherapy With Epirubicin, Paclitaxel, and Cyclophosphamide... Moebus et al. J Clin Oncol.2010; 0: JCO.2009.24.7643v1-JCO.2009.24.7643 | ||
| 36826820 |
| Label | URL |
|---|---|
| http://www.ncbi.nlm.nih.gov/pubmed/20458045 | View source |
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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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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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| Epirubicin, Paclitaxel | Drug | Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles. |
|
| Derived |
| Yuan P, Kang Y, Ma F, Fan Y, Wang J, Wang X, Yue J, Luo Y, Zhang P, Li Q, Xu B. Effect of Epirubicin Plus Paclitaxel vs Epirubicin and Cyclophosphamide Followed by Paclitaxel on Disease-Free Survival Among Patients With Operable ERBB2-Negative and Lymph Node-Positive Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230122. doi: 10.1001/jamanetworkopen.2023.0122. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |