drugset / Trial / NCT00427427

Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer

NCT00427427 ↗

Phase 2 Terminated 75 enrolled Jonsson Comprehensive Cancer Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to determine what factors affect a patient's decision to accept delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or radiation therapy. Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004 or thereafter and who have completed surgery and primary treatment earlier will be potentially eligible. Patients will be asked to complete a questionnaire about their breast cancer and reasons why they may or may not accept Herceptin® treatment. Patients will be given the option to (1) receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to receive Herceptin® but agree to annual doctor visits for 5 years.

Timeline

Start
2007-01
Primary completion
—
Completion
2007-10

Outcome

Outcome not reported

Stopped (Enrollment): “lack of accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody — —

Indications