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FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

NCT00129389 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1925

Last updated 2023-03-07

Study results available
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Summary

This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative).

Conditions

Interventions

DRUG

Fluorouracil

Arm A: FAC Arm B: FAC-wP

DRUG

Doxorubicin

Arm A: FAC Arm B: FAC-wP

DRUG

Cyclophosphamide

Arm A: FAC Arm B: FAC-wP

DRUG

Paclitaxel

Arm B: FAC-wP

Sponsors & Collaborators

Principal Investigators

  • Study Director · Hospital Universitario San Carlos

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
2003-09-19
Primary Completion
2013-10-01
Completion
2013-10-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00129389 on ClinicalTrials.gov