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Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.

NCT00314977 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-03-18

No results posted yet for this study

Summary

2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer.

Conditions

Interventions

DRUG

Doxorubicin

doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2)

DRUG

Cyclophosphamide

Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2)

DRUG

Docetaxel

Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • V.C.G. Tjan-Heijnen · AZM Maastricht

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
2006-02-28
Primary Completion
2009-04-30

Countries

  • Netherlands

Study Locations

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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 NCT00314977 on ClinicalTrials.gov