Clinical Trials Logo

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
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


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


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.


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


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


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
See also
Status Clinical Trial Phase
 Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
 Recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
 Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy N/A
 Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
 Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
 Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
 Recruiting NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer Phase 2
 Recruiting NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy N/A
 Not yet recruiting NCT03176888 - Health Benefits of HIT for Breast Cancer Patients N/A
 Not yet recruiting NCT02767661 - Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer Phase 3
 Recruiting NCT02894398 - Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant Phase 2
 Recruiting NCT02903524 - Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer Phase 4
 Recruiting NCT02897544 - Integrative Approaches for Cancer Survivorship 2: Project 2 N/A
 Recruiting NCT02897635 - Integrative Approaches For Cancer Survivorship 2: Project 1 N/A
 Recruiting NCT02980848 - Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study N/A
 Recruiting NCT02897050 - Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer Phase 2
 Recruiting NCT02913729 - Pre- Versus Postoperative Accelerated Partial Breast Irradiation N/A
 Recruiting NCT02840344 - Couples-Based Mindfulness for Young Breast Cancer Survivors N/A
 Recruiting NCT03080155 - A Study of the 3D MIRA System in Classifying Women at for Likelihood of Breast Cancer N/A
 Recruiting NCT02035085 - 19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction Phase 1