A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
Public ClinicalTrials.gov record NCT02236000. 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 Ib/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being done for the following reasons: * The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1. * The purpose of the second part of the study (Phase II) is to find out whether the dose of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time. * In order to learn more about study therapy levels in blood and discover genetic and protein changes associated with cancer, the study includes special research tests using samples from blood and from breast tumor. Blood samples will be collected before study treatment, once during treatment, and after study treatment stops. * In the optional part of this study, three biopsies will be performed to obtain fresh tumor samples from an area where your cancer has spread.
Study identification
- NCT ID
- NCT02236000
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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
- Jul 31, 2014
- Primary completion
- Nov 30, 2020
- Completion
- Jul 31, 2021
- Last update posted
- Jan 25, 2023
2014 – 2021
United States locations
- U.S. sites
- 15
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic Weston | Weston | Florida | 33331 | — |
| Cancer Care Specialists of Central Illinois | Decatur | Illinois | 62526 | — |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | — |
| Cancer Care Specialists of Central Illinois-Swansea | Swansea | Illinois | 62226 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Stephenson Cancer Center at the University of Oklahoma Health Services Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC- Hillman Cancer Center-Monroeville | Monroeville | Pennsylvania | 15146 | — |
| Alleheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15213 | — |
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC- St. Margaret | Pittsburgh | Pennsylvania | 15215 | — |
| UPMC Hillman Cancer Center North Hills at Passavant | Pittsburgh | Pennsylvania | 15237 | — |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| West Virginia University | Morgantown | West Virginia | 26501 | — |
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 NCT02236000, 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 Jan 25, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02236000 live on ClinicalTrials.gov.