MedTrace Logo

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

NCT00542451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2024-06-26

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.

Conditions

Interventions

DRUG

Paclitaxel

Every week for 12 weeks

DRUG

Trastuzumab

Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks

Sponsors & Collaborators

Principal Investigators

  • Sara Tolaney, MD, MPH · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2014-04-21
Completion
2022-08-30

Countries

  • United States

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 NCT00542451 on ClinicalTrials.gov