Breast Cancer Clinical Trial
Official title:
Phase 3 Study of Regimens Comparison for Breast Cancers of Positive Lymph Nodes
To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Cancer Institute & Hospital. Chinese Academy of Medical Sciences | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences |
China,
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 |
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