A Randomized, Phase II Study Comparing DA (Paclitaxel, Pirarubicin) With DAC ( Paclitaxel, Pirarubicin，Cyclophosphamide) as Postoperative Adjuvant Treatment for Early-stage Breast Cancer

Peking Union Medical College Hospital0 sites300 target enrollmentJanuary 2009

ConditionsBreast Cancer

InterventionsDocetaxel, Doxorubicin Docetaxel, Doxorubicin, Cyclophosphamide

DrugsDocetaxel, Doxorubicin Docetaxel, Doxorubicin, Cyclophosphamide

Overview

Phase: Phase 2
Intervention: Docetaxel, Doxorubicin
Conditions: Breast Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 300
Primary Endpoint: Disease-free survival
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Our study is a prospective, non-inferior, randomized phase II clinical trial, to compare the efficacy and safety profiles of DA versus DAC as adjuvant chemotherapy regimens for early-stage breast cancer patients.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Principal Investigator

Qiang SUN

Chief of Dept. Breast Surgery, Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•Age \>= 18 and \<= 70 years old.
•Performance status (Karnofsky index) \>=
•Histological diagnosis of invasive breast cancer (T1-T3,N0-1,M0). Time window between surgery and study randomization must be less than 60 days.
•Surgery must consist of mastectomy or conserving surgery with axillary lymph node dissection.
•Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected.
•Status of hormone receptors, HER2 status, Ki-67 index and p53 in primary tumour. Results must be available before the end of adjuvant chemotherapy.
•Written informed consent. Patients are able to comply with treatment and study follow-up.
•Patients must not present evidence of metastatic disease.
•Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).
•Laboratory results (within 14 days prior to randomization):

Exclusion Criteria

•Prior systemic therapy for breast cancer.Or prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
•Prior radiotherapy for breast cancer.
•Bilateral invasive breast cancer.
•Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.
•Any T4 or N2-3 or M1 tumour.
•Pre-existing grade \>= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 \[NCI CTC v-2.0\]).
•Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled HA or high risk arrhythmias.
•History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.
•Active uncontrolled infection.
•Active peptic ulcer; unstable diabetes mellitus.