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Phase 3 Study of Regimens Comparison for Breast Cancers of Positive Lymph Nodes


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase 3 Study of Regimens Comparison for Breast Cancers of 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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PFS

Outcome Time Frame:

5 years after all the recuiment

Safety Issue:

Yes

Principal Investigator

Binghe Xu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Academy of Medical Sciences

Authority:

China: Ministry of Health

Study ID:

CH-BC-006

NCT ID:

NCT01134523

Start Date:

May 2010

Completion Date:

May 2020

Related Keywords:

  • Breast Cancer
  • positive lymph node
  • Breast Neoplasms

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