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Tyrosine Kinase Inhibitor
Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer
Phase 2
Waitlist Available
Led By Priyanka Sharma, M.D.
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
Primary Study Objective: To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant chemotherapy plus erlotinib in patients with triple negative breast cancer.
Eligible Conditions
- Breast Cancer
Timeline
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
Side effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Vomiting
14%
Neutropenia
14%
White blood cell count decreased
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Musculoskeletal pain
5%
Dizziness
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: erlotinib with neoadjuvant chemotherapyExperimental Treatment1 Intervention
Study drug, erlotinib, is administered along with neoadjuvant chemotherapy. Adjuvant therapy given at discretion of treating physician. Once adjuvant therapy is completed, all patients will receive erlotinib 150 mg daily for 1 year.
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
517 Previous Clinical Trials
177,409 Total Patients Enrolled
22 Trials studying Breast Cancer
4,344 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,968 Total Patients Enrolled
96 Trials studying Breast Cancer
23,130 Patients Enrolled for Breast Cancer
Priyanka Sharma, M.D.Principal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
72 Total Patients Enrolled