Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer
Status:
Terminated
Trial end date:
2020-05-29
Target enrollment:
Participant gender:
Summary
Primary Objective:
• Determination of pathologic complete response (pCR) rates
Secondary Objective:
- Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain
and troponin.
- Breast conservation rates
- Overall survival
Study Design
- Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will
be enrolled.
- Patients will be stratified by ER/PR status.
- They will be randomized to ddACTHP vs TCHP.
- Initially, 17 patients will be randomly assigned to each treatment arm.
- If 3 or fewer patients have a pCR, then that arm will be terminated and no further
patients will be entered on that treatment arm.
- If 4 or more patients obtain a pCR, 20 additional patients (total of 37 patients)
will be randomized to that treatment arm.
- If 11 or more patients out of 37 have a pCR, the treatment will be of interest for
further study.