Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer
Phase II Trial of Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer
1 other identifier
interventional
32
1 country
10
Brief Summary
This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2006
Longer than P75 for phase_2
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
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 27, 2006
CompletedFirst Posted
Study publicly available on registry
January 31, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
August 9, 2013
CompletedAugust 9, 2013
July 1, 2013
2.1 years
January 27, 2006
March 25, 2013
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
18 months
Study Arms (2)
HER2 Negative Intervention
EXPERIMENTALVinflunine 320 mg/m2 intravenously day 1 over 20 minutes, repeated every 21 days
HER2 Positive Intervention
EXPERIMENTALVinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2.
Interventions
Novel second generation vinca alkaloid
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed breast cancer with metastatic disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- The human epidermal growth factor receptor 2 (HER2) status of the tumor will be used to stratify patients. Tumors that are HER2 FISH+ will receive vinflunine and trastuzumab. Patients with tumors which are HER2 FISH negative or if the HER2 status is unknown/not performed will remain on study and will receive single agent vinflunine.
- Patients must have measurable disease not directly irradiated as per RECIST criteria.
- Measurable disease- is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
- Age \>18 years.
- Life expectancy of \> 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status \<2.
- Patients must have normal organ and marrow function. Laboratory tests should be completed within 14 days prior to starting study treatment. Only for patients who will be receiving trastuzumab, a left ventricular ejection fraction (LVEF) may be determined by either echocardiography or multigated acquisition (MUGA) scan, and should be obtained within 4 weeks prior to starting study treatment.
- Fertility/reproduction. Patients must not be pregnant, expect to become pregnant or conceive a child from time of first signing study consent until at least 12 weeks after last dose of study treatment.
You may not qualify if:
- Patients who have received prior vinca alkaloid chemotherapy are not eligible unless treatment was completed \> 5 years ago.
- Patients in which the HER2 status is unknown or is FISH negative will not receive trastuzumab but are eligible for treatment with single agent vinflunine.
- Patients that have received prior chemotherapy for metastatic breast cancer.
- Patients receiving trastuzumab must have received a cumulative dose of doxorubicin less than 360mg/m2, and/or an epirubicin cumulative dose less than 720mg/m2 for study entry.
- Patients with known leptomeningeal carcinomatosis are excluded from this clinical trial
- History of grade 3 or 4 allergic reactions attributed to trastuzumab.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study
- History of other non-breast cancer malignancy except for carcinoma in situ of the cervix or non-melanoma skin cancer, or in patients with greater than a 5-year disease free interval from a prior malignancy.
- Patients who have received prior chemotherapy for early stage breast cancer with the completion of the regimen being \< 6 months will not be eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Bristol-Myers Squibbcollaborator
Study Sites (10)
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Hematology Oncology Life Center
Alexandria, Louisiana, 71301, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Associates in Hematology Oncology
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37205, United States
Related Publications (1)
Yardley DA, McCleod M, Schreiber F, Murphy P, Patton J, Thompson DS, Shastry M, Rubin M, Melnik M, Burris HA, Hainsworth JD. A phase II trial of vinflunine as monotherapy or in combination with trastuzumab as first-line treatment of metastatic breast cancer. Cancer Invest. 2010 Nov;28(9):925-31. doi: 10.3109/07357907.2010.496755.
PMID: 20690806RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Denise A Yardley, 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2006
First Posted
January 31, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2008
Study Completion
November 1, 2010
Last Updated
August 9, 2013
Results First Posted
August 9, 2013
Record last verified: 2013-07