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Tyrosine Kinase Inhibitor
Sorafenib and Vinorelbine for Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Lawrence Panasci
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women affected by histologically proven metastatic breast cancer.
Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification or immunohistochemistry 0-1+ for HER-2 expression.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer. The investigators are combining these 2 drugs in order to determine if the investigators can increase the activity of vinorelbine in metastatic breast cancer patients. Patients with measurable metastatic breast cancer without previous chemotherapy for metastatic disease are eligible for the protocol. They will be treated with 2 different dose levels of sorafenib in order to determine the most tolerable dose.
Eligible Conditions
- Breast Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sorafenib and VinorelbineExperimental Treatment1 Intervention
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Who is running the clinical trial?
McGill UniversityLead Sponsor
392 Previous Clinical Trials
984,693 Total Patients Enrolled
5 Trials studying Breast Cancer
210 Patients Enrolled for Breast Cancer
Lawrence PanasciPrincipal InvestigatorMcGill University
Frequently Asked Questions
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