Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status
Public ClinicalTrials.gov record NCT03457896. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study Evaluating the Combination of Neratinib Plus Trastuzumab or Neratinib Plus Cetuximab in Patients With "Quadruple Wild-Type" (KRAS/NRAS/BRAF/PIK3CA Wild-Type) Metastatic Colorectal Cancer Based on HER2 Status: Amplified, Non-Amplified (Wild-Type) or Mutated
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase II trial to examine the efficacy of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (all RAS/NRAS/BRAF/PIK3CA wild-type), metastatic colorectal cancer based on HER2 status (amplified, non-amplified \[wild-type\] or mutated). Patients must have confirmed quadruple wild-type (WT) genotype, via NSABP MPR-1 or from colonic biopsy or a metastatic biopsy taken prior to treatment, and known HER2 status.
Study identification
- NCT ID
- NCT03457896
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Interventions
- Trastuzumab Drug
- Cetuximab Drug
- Neratinib Drug
- Guardant360 Diagnostic Test Diagnostic Test
Drug · Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2018 (Actual)
- Primary completion
- Sep 30, 2021 (Actual)
- Completion
- Sep 30, 2022 (Estimated)
- Last update posted
- Mar 31, 2022
2018 – 2022
United States locations
- U.S. sites
- 48
- U.S. states
- 8
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente-Anaheim | Anaheim | California | 92806 | — |
| Kaiser Permanente-Baldwin | Baldwin Park | California | 91706 | — |
| Kaiser Permanente-Bellflower | Bellflower | California | 90706 | — |
| Kaiser Permanente-Fontana | Fontana | California | 92335 | — |
| Kaiser Permanente-Harbor City | Harbor City | California | 90710 | — |
| Kaiser Permanente-Irvine | Irvine | California | 92618 | — |
| Kaiser Permanente-Sunset | Los Angeles | California | 90027 | — |
| Kaiser Permanente-West Los Angeles (Cadillac) | Los Angeles | California | 90034 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Kaiser Permanente-Panorama City | Panorama City | California | 91402 | — |
| Kaiser Permanente-Riverside | Riverside | California | 92505 | — |
| Kaiser Permanente-Roseville | Roseville | California | 95661 | — |
| Kaiser Permanente-Sacramento | Sacramento | California | 95814 | — |
| Kaiser Permanente-Medical Group | San Diego | California | 92108 | — |
| Kaiser Permanente-Zion | San Diego | California | 92120 | — |
| Kaiser Permanente-San Francisco | San Francisco | California | 94115 | — |
| Kaiser Permanente-San Jose | San Jose | California | 95119 | — |
| Kaiser Permanente-San Leandro | San Leandro | California | 94577 | — |
| Kaiser Permanente-San Marcos | San Marcos | California | 92078 | — |
| Kaiser Permanente Medical Center Santa Clara | Santa Clara | California | 95051 | — |
| Kaiser Permanente-South San Francisco | South San Francisco | California | 94080 | — |
| Kaiser Permanente-Vallejo | Vallejo | California | 94589 | — |
| Kaiser Permanente-Walnut Creek | Walnut Creek | California | 94596 | — |
| Kaiser Permanente-Woodland Hills | Woodland Hills | California | 91367 | — |
| UF Health Davis Cancer Pavilion and Shands Medical Plaza | Gainesville | Florida | 32608 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Cancer Care Specialists of Central IL-Decatur | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Crosslands Cancer Center | Effingham | Illinois | 62401 | — |
| Cancer Care Specialists of Central IL-Swansea | Swansea | Illinois | 62226 | — |
| Trinity Health Michigan | Ann Arbor | Michigan | 48106 | — |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | — |
| St. Joseph Mercy Brighton | Brighton | Michigan | 48114 | — |
| St. Joseph Mercy Canton | Canton | Michigan | 48188 | — |
| St. Joseph Mercy Chelsea | Chelsea | Michigan | 48118 | — |
| Cancer Research Consortium of West Michigan | Grand Rapids | Michigan | 49503-2560 | — |
| Spectrum Health Butterworth | Grand Rapids | Michigan | 49503 | — |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | — |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | — |
| St. Mary's of Michigan | Saginaw | Michigan | 48601 | — |
| Lakeland Healthcare-Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | — |
| Metro Health Hospital | Wyoming | Michigan | 49519 | — |
| Minnesota Oncology-Fridley | Saint Louis Park | Minnesota | 55432 | — |
| Thomas Jefferson University Hospital-Sidney Kimmel Cancer Network | Philadelphia | Pennsylvania | 19107 | — |
| Wellmont Cancer Institute | Johnson City | Tennessee | 37601 | — |
| Wellmont Cancer Institute | Kingston | Tennessee | 37660 | — |
| Wellmont Medical Associates-Oncology and Hematology | Bristol | Virginia | 24201 | — |
| Southwest Virginia Regional Cancer Center | Norton | Virginia | 24273 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03457896, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 31, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03457896 live on ClinicalTrials.gov.