A Randomized, Phase II Study Comparing Single X (Xeloda/Capetabine) With Placebo as Postoperative Adjuvant Treatment for Elder Breast Cancer

Peking Union Medical College Hospital1 site in 1 country300 target enrollmentJanuary 2014

ConditionsBreast Cancer

InterventionsCapecitabine Placebo

DrugsCapecitabine Placebo

Overview

Phase: Phase 2
Intervention: Capecitabine
Conditions: Breast Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 300
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

Our study is a prospective, randomized phase II clinical trial, to compare the efficacy and safety profiles of single X versus placebo as adjuvant chemotherapy regimens for elder 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

•Inclusion Criteria:
•Age \>= 70 years old.
•Performance status (Karnofsky index) \>=
•Histological diagnosis of invasive breast cancer (T3-T4,N0-1,M0). Tumor must bu hormone receptor negative. Time window between surgery and study randomization must be less than 60 days.
•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. ER and PR negative. And patients with positive HER-2 status should revceive the standard anti-targeted therapy.
•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 capecitabine for any malignancy.
•Prior radiotherapy for breast cancer.
•Bilateral invasive breast cancer.
•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.
•Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.