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Combination Chemotherapy and Trastuzumab in Treating Women With Stage I, Stage II, or Stage III HER2-Positive Breast Cancer

NCT00629278 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2013-08-07

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with trastuzumab is most effective in treating breast cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of combination chemotherapy given together with trastuzumab to see how well they work in treating women with HER2-positive stage I, stage II, or stage III breast cancer.

Conditions

Interventions

BIOLOGICAL

trastuzumab

DRUG

aromatase inhibition therapy

DRUG

cyclophosphamide

DRUG

docetaxel

DRUG

doxorubicin hydrochloride

DRUG

epirubicin hydrochloride

DRUG

fluorouracil

DRUG

paclitaxel

DRUG

releasing hormone agonist therapy

DRUG

tamoxifen citrate

PROCEDURE

adjuvant therapy

RADIATION

radiation therapy

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

    lead OTHER

Principal Investigators

  • Pier Franco Conte, MD · Azienda Ospedaliero-Universitaria di Modena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00629278 on ClinicalTrials.gov