Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer
Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)
1 other identifier
interventional
63
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Apr 2008
Shorter than P25 for phase_2 breast-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
December 20, 2012
CompletedNovember 24, 2021
November 1, 2021
6 months
February 26, 2008
August 22, 2012
November 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel
18 Months
Secondary Outcomes (2)
Disease-free Survival
18 Months
Overall Survival
18 Months
Study Arms (1)
Intervention
EXPERIMENTAL100 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.
Interventions
100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast cancer, with an interval between definitive breast surgery and study registration of \<60 days.
- 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.
You may not qualify if:
- Patients who are pregnant or breastfeeding.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Celgene Corporationcollaborator
Study Sites (10)
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Mercy Hospital
Portland, Maine, 04101, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Related Publications (1)
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.
PMID: 20658263RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Breast Cancer Research
- Organization
- Sarah Cannon Research Institute
Study Officials
- STUDY CHAIR
John Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 6, 2008
Study Start
April 1, 2008
Primary Completion
October 1, 2008
Study Completion
September 1, 2010
Last Updated
November 24, 2021
Results First Posted
December 20, 2012
Record last verified: 2021-11