Regimens Comparison for Breast Cancers of Positive Lymph Nodes

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Epirubicin, CTX, Paclitaxel; Drug: Epirubicin, Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01134523

CH-BC-006

Details and patient eligibility

About

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

Full 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

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

Group A: EC-T regimen

Active Comparator group

Treatment:

Drug: Epirubicin, CTX, Paclitaxel

Group B: ET regimen

Experimental group

Treatment:

Drug: Epirubicin, Paclitaxel