This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study.
Given the favorable activity demonstrated in a trial using the taxane docetaxel in combination with cyclophosphamide, we propose a Phase II trial of 4 cycles of weekly nab paclitaxel combined with cyclophosphamide. The favorable toxicity profile for weekly nab paclitaxel, in addition to its demonstrated superiority over standard paclitaxel in early-stage breast cancer, makes it an ideal taxane to evaluate in this setting. In this study, nab paclitaxel will be administered once weekly, in combination with q3wk cyclophosphamide. By using this combination therapy method, the goal of this study is to maximize the opportunity to demonstrate improved tolerability of adjuvant nab paclitaxel using a weekly dosing schedule in combination with q3wk cyclophosphamide. In this study, patients who demonstrate FISH or IHC3+ HER2 positivity and adequate cardiac function will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Trastuzumab will be administered IV using an 8 mg/kg loading dose on Day 1 of the treatment period. If no toxicity occurs, subsequent doses of trastuzumab will be administered IV as a 6 mg/kg dose approximately every 21 days for a total of 52 weeks (thus, maintenance therapy with trastuzumab will continue after the 12-week period of combination therapy with nab paclitaxel/cyclophosphamide/trastuzumab has ended).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)
600 mg/m2 of IV cyclophosphamide
8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel
Time frame: 18 Months
Disease-free Survival
Number of participants that are disease free at 18th month
Time frame: 18 Months
Overall Survival
Number of participants that are alive at 18th month
Time frame: 18 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mercy Hospital
Portland, Maine, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
St. Louis Cancer Care
Chesterfield, Missouri, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Peninsula Cancer Institute
Newport News, Virginia, United States