A Randomized, Phase II Study Comparing Standard Chemotherapy (TA-Taxol+Epirubicin or TAC-Taxol+Epirubicin+Cyclophosphamide) With Standard Chemotherapy (TA or TAC) Followed by Capecitabine (X) as Prolonged Postoperative Adjuvant Treatment for Breast Cancer

Peking Union Medical College Hospital1 site in 1 country500 target enrollmentJanuary 2014

ConditionsBreast Cancer

InterventionsTA or TAC X

DrugsTA or TAC X

Overview

Phase: Phase 2
Intervention: TA or TAC
Conditions: Breast Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 500
Locations: 1
Primary Endpoint: Disease-free survival
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a prospective, randomized phase II clinical trial, to compare the efficacy and safety profiles of standard chemotherapy versus standard chemotherapy followed by capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

January 2020

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-T4,N2-3,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 adjuvant chemotherapy. All patients require the TA or TAC chemotherapy. And patients should receive the endocrine chemotherapy or anti-targeted therapy according to the hormone receptor status or HER2 status respectively.
•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 N0-1 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.