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Monoclonal Antibodies

Trastuzumab for Colorectal Cancer

Phase 2
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
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 from initiation of neratinib plus cetuximab therapy to time of tumor assessment between cycles 6 and 7, which is usually 6 months after start of therapy
Awards & highlights

Study Summary

This trial will examine if adding neratinib to trastuzumab or cetuximab improves outcomes in patients with metastatic colorectal cancer that have a certain gene makeup.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of neratinib plus trastuzumab therapy to time of tumor assessment, between cycle 6 and 7,which is usually six months after start of therapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of neratinib plus trastuzumab therapy to time of tumor assessment, between cycle 6 and 7,which is usually six months after start of therapy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS) with neratinib plus cetuximab therapy
Progression free survival with neratinib plus trastuzumab therapy
Secondary outcome measures
Clinical benefit rate
Frequency of adverse events assessed using CTCAE 4.0
Overall response rate to study therapy

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment2 Interventions
Patients with HER2 Wild Type or HER2 amplified with no prior anti-EGFR therapy will receive: • Neratinib daily + Cetuximab weekly until disease progression
Group II: Arm 1Experimental Treatment3 Interventions
Guardant360 test on blood from select patients with known HER2 status. Prior to assignment to Arm 1, HER2 test on blood obtained from Quadruple Wild-Type patients who received anti-EGFR therapy. Patients with HER2 amplified, HER2 Wild-Type or HER2 mutated will recieve: • Neratinib daily + Trastuzumab weekly until disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Cetuximab
2011
Completed Phase 3
~2480
Neratinib
2014
Completed Phase 2
~1970

Find a Location

Who is running the clinical trial?

Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
9,907 Total Patients Enrolled
NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
136,953 Total Patients Enrolled
Norman Wolmark, MDPrincipal InvestigatorNSABP Foundation Inc
59 Previous Clinical Trials
83,682 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
Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status
2018. "Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03457896.
All > Rectal Cancer
~5 spots leftby May 2025
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