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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01134523
Other study ID # CH-BC-006
Secondary ID
Status Recruiting
Phase Phase 3
First received June 1, 2010
Last updated March 14, 2013
Start date May 2010
Est. completion date May 2020

Study information

Verified date March 2013
Source Chinese Academy of Medical Sciences
Contact Peng Yuan, M.D.
Phone 86-10-8778 8114
Email yuanpeng01@hotmail.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date May 2020
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old

Exclusion Criteria:

- with other malignance disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Epirubicin, CTX, Paclitaxel
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.
Epirubicin, Paclitaxel
Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.

Locations

Country Name City State
China Cancer Institute & Hospital. Chinese Academy of Medical Sciences Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences,

Country where clinical trial is conducted

China, 

References & Publications (2)

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PFS 5 years after all the recuiment Yes
Secondary OS 5 years after all the adjuvent treatments Yes
Secondary Safety Assessing for Hematology and Non-hematology toxicities, including all SAEs. 5 years after all the recruiment Yes
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