AX Versus AC as Adjuvant Treatment for Node-Negative Breast Cancer

NCT01415336 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-08-11

No results posted yet for this study

Summary

Capecitabine has shown high efficacy in metastatic and adjuvant settings. This is a prospective, randomised trial, to compare the efficacy and safety profiles of capecitabine-containing regimen with non- capecitabine-containing adjuvant chemotherapy regimens for node negative breast cancer patients.

Conditions

Interventions

DRUG

Doxorubicin, Cyclophosphamide

doxorubicin 60 mg/m², iv, day 1; Cyclophosphamide 600 mg/m², iv, day 1; every 3 weeks for 4 cycles

DRUG

doxorubicin, Capecitabine

doxorubicin 60 mg/m², iv, day 1; capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14; every 3 weeks for 4 cycles

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Qiang Sun, Master · PUMCH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-03-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415336 on ClinicalTrials.gov