CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 406 enrolled
Drug / intervention
Paclitaxel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00542451
NCT00542451Phase 2Completed

A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

Dana-Farber Cancer Institute·interventional·Posted Oct 11, 2007·Updated Jun 26, 2024

In Brief

A Phase 2 clinical trial evaluating Paclitaxel and Trastuzumab for Breast Cancer and Carcinoma of the Breast. Completed, enrolled 406 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2007
Enrollment StartOct 1, 2007
Primary CompletionApr 21, 2014
Study CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 18.7 years ago

Interventions

Paclitaxeldrug

Every week for 12 weeks

Trastuzumabdrug

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