Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)
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).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerability of Adjuvant Nab Paclitaxel Using Weekly Dosing Schedule Assessed by Patient Survival, Disease Recurrence, and Treatment-related Toxicity.
18 Months
No
John Hainsworth, MD
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI BRE 116
NCT00629499
April 2008
September 2010
Name | Location |
---|---|
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Cancer Care of Western North Carolina | Asheville, North Carolina 28801 |
Mercy Hospital | Portland, Maine 04101 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Gulfcoast Oncology Associates | St. Petersburg, Florida 33705 |
St. Louis Cancer Care | Chesterfield, Missouri 63017 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Watson Clinic Center for Cancer Care and Research | Lakeland, Florida 33805 |