NCT00542451

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Participants will enroll in this study at the time they are starting their adjuvant therapy for breast cancer. Participants will receive chemotherapy with paclitaxel every week for 12 weeks. They will begin to receive trastuzumab at the same time they begin paclitaxel. Once they have completed the 12 weeks of paclitaxel and trastuzumab, they will receive trastuzumab every 3 weeks or weekly for 40 weeks. * Participants will be followed with routine assessments such as physical exam and vital signs every 3 months for the first year, and then every 6 months for years 2-5. Then we would like to keep track of the participants medical condition by calling them on the telephone once per year.

Conditions

• Breast Cancer
• Carcinoma of the Breast

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-10-01
• Primary completion: 2014-04-21
• Completion: 2022-08-30
• First posted: 2007-10-11
• Last updated: 2024-06-26
• Results posted: 2023-03-27

Locations

20 sites across 1 country: United States