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NCT02038010 · ClinicalTrials.gov registry record · Phase 1
BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02038010 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 17 participants.
The verdict
NCT02038010, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab) linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this study is considered standard treatment for the type of cancer in this study. Participants in this study have already been treated with trastuzumab and chemotherapy in the past, and their cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth) that the researchers think may help T-DM1 to work better.
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG PI3K inhibitor BYL719
- BIOLOGICAL ado-trastuzumab emtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-05-21 |
| Est. Completion | 2017-05-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02038010
The ClinicalTrials.gov registry entry for NCT02038010 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT02038010 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02038010 about?
NCT02038010 is a clinical study titled "BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx". The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab) linked to chemotherapy. The antibody i...
What is the current status of trial NCT02038010?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-05-21. Estimated completion is 2017-05-20.
What interventions are being tested in trial NCT02038010?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), PI3K inhibitor BYL719 (DRUG), ado-trastuzumab emtansine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02038010?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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