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Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer

NCT00544765 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2014

Last updated 2021-02-04

No results posted yet for this study

Summary

Primary objective of the study in patients without a sufficient sonographic response (i.e. iNC) to 2 cycles of TAC as preoperative treatment of operable (T\>/= 2cm, N0-2,M0) primary breast cancer: To determine the response rate determined by sonography (iRR = iCR+iPR) of further 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) and of 4 cycles of vinorelbine and capecitabine (NX) (TAC vs. NX)

Primary objective of the study in patients with a sufficient sonographic response (i.e. iRR = iPR or iCR) to the first 2 cycles of TAC as preoperative treatment of operable (T\>/=2cm, N0-2,M0) primary breast cancer: To determine the pCR rate of 6 cycles vs. 8 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC x 6 vs. TAC x 8)

Conditions

Interventions

DRUG

TAC

Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks

DRUG

NX

Vinorelbine 25 mg/m² as a \< 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Goethe University

    collaborator OTHER

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Gunter von Minckwitz, MD · GBG Forschungs GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2008-02-29
Completion
2008-02-29

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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 NCT00544765 on ClinicalTrials.gov