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Tyrosine Kinase Inhibitor

erlotinib with neoadjuvant chemotherapy for 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 12 months
Awards & highlights

Study 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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathological complete response rate (pCR)
Secondary outcome measures
Assessment of tolerability of 12 months of maintenance erlotinib treatment
Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib
Pharmacotherapy
+1 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

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
464 Previous Clinical Trials
169,243 Total Patients Enrolled
22 Trials studying Breast Cancer
4,478 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,111 Total Patients Enrolled
96 Trials studying Breast Cancer
23,186 Patients Enrolled for Breast Cancer
Priyanka Sharma, M.D.Principal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
72 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer
2007. "Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00491816.
All > Breast
~2 spots leftby May 2025
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