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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

No Placebo-Only Group

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 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS) with neratinib plus cetuximab therapy

Progression free survival with neratinib plus trastuzumab therapy

Secondary study objectives

Clinical benefit rate

Frequency of adverse events assessed using CTCAE 4.0

Overall response rate to study therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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