Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective
treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20),
surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period
(approximately 3 years). Subjects will be treated on an outpatient basis.
Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for
four cycles followed by a three week break. Subjects will then receive docetaxel every two
weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks
for 4 treatments.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.
From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
Lee S Schwartzberg, MD, FACP
Accelerated Community Oncology Research Network, Inc. (ACORN)
United States: Food and Drug Administration
|Arena Oncology Associates||Great Neck, New York 11021|
|Augusta Oncology Associates||Augusta, Georgia 30901|
|The West Clinic||Memphis, Tennessee 38120|
|Advanced Medical Specialties||Miami, Florida 33176|
|Cental Georgia Cancer Care||Macon, Georgia 31201|
|Northwest Georgia Oncology Centers, PC||Marietta, Georgia 30060|
|Hematology Oncology Centers of the Northern Rockies, PC||Billings, Montana 59101|