Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer
NCT ID: NCT00629499
Last Updated: 2021-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2008-04-30
2010-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks \[84 days\]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
nab paclitaxel
100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)
Cyclophosphamide
600 mg/m2 of IV cyclophosphamide
Trastuzumab
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.
Interventions
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nab paclitaxel
100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)
Cyclophosphamide
600 mg/m2 of IV cyclophosphamide
Trastuzumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Definitive surgical treatment must be either mastectomy or breast-conserving therapy with axillary lymph node dissection for operable breast cancer (pT1 4 \[including inflammatory breast cancer\], pN0 3, and M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
* Patients with ≥1 axillary lymph node containing metastatic adenocarcinoma measuring \>0.2 mm, OR lymph node-negative patients with high-risk features
* Patients with HER2/neu positive or negative tumors (HER2 positivity must be documented by FISH positivity or IHC 3+).
* Patients who are to receive trastuzumab must have normal cardiac function (MUGA \[cardiac ejection fraction \>50%, or greater than or equal to the institutional lower limit of normal\], or echocardiogram \[ECHO\] within institutional normal limits).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
* Patients who are either chemotherapy naïve, or who have received prior chemotherapy \>5 years ago.
* Patients with previous invasive cancers (including breast cancer) eligible only if treated \>5 years prior to entering this study, and show no evidence of recurrent disease.
* Adequate bone marrow function
* Adequate liver function,
* Adequate renal function,
* Patients of childbearing potential must use an effective method of contraception that is acceptable to their study physician from the time of signing informed consent until at least 3 months after the last dose of protocol treatment, and must have a negative pre study serum pregnancy test.
* Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria.
* MammoSite® brachytherapy radiation accepted when performed immediately following surgery and prior to receiving chemotherapy.
Exclusion Criteria
* M1 metastatic disease.
* Patients requiring neoadjuvant chemotherapy.
* Life expectancy of greater than 6 months.
* History of cardiac disease, with a New York Heart Association (NYHA) Class II or greater CHF
* Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment, any history of stroke or transient ischemic attack at any time, clinically significant peripheral vascular disease, or evidence of a bleeding diathesis or coagulopathy.
* Any investigational agent within 30 days of receiving the first dose of study drug.
* Treatment with prior trastuzumab or bevacizumab therapy.
* Concurrent treatment with any other anti-cancer therapy is not permitted.
* History of significant psychiatric disorders.
* History of active, uncontrolled infection.
* A serious, non-healing wound, ulcer, or bone fracture.
* Any other diseases, metabolic dysfunction, findings from a physical examination, or clinical laboratory test results that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results or that renders the patient at high risk from treatment complications.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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John Hainsworth, MD
Role: STUDY_CHAIR
SCRI Development Innovations, LLC
Locations
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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
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
Countries
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References
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Yardley D, Burris H 3rd, Peacock N, Raefsky E, Melnik M, Inhorn R, Shipley D, Hainsworth J. A pilot study of adjuvant nanoparticle albumin-bound (nab) paclitaxel and cyclophosphamide, with trastuzumab in HER2-positive patients, in the treatment of early-stage breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):471-5. doi: 10.1007/s10549-010-1047-0. Epub 2010 Jul 24.
Related Links
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Other Identifiers
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SCRI BRE 116
Identifier Type: -
Identifier Source: org_study_id