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NCT01875666 · ClinicalTrials.gov registry record · Early Phase 1
Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib
A Early Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
NCT01875666 is a Early Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 26 participants.
The verdict
NCT01875666, a Early Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind of kinase. This study looks at a new approach to identifying kinases, which may help target therapy more precisely. LCCC1214 is a randomized, multiarm, multicenter, open-label window trial designed to explore the kinome response in Stage I-IV HER2 positive (HER2+) breast cancer patients scheduled to undergo definitive surgery (either lumpectomy, mastectomy or surgical resection of oligometastatic disease). Patients will initiate dosing with either a single HER2-directed agent or a combination of two HER2-directed agents, one week prior to surgery. Forty patients will be randomized to one of four study groups: A) single dose trastuzumab; B) single dose pertuzumab; C) combination single dose trastuzumab plus single dose pertuzumab; or D) combination single dose trastuzumab plus lapatinib daily for 7 days. Pre- and post- dosing tissue will be analyzed for kinome response and resistant signatures. The initiation of study drug will be defined by the surgical schedule; there will be no delays in standard treatment for the purposes of this study.
Interventions
- DRUG Trastuzumab
- DRUG pertuzumab
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-08-05 |
| Est. Completion | 2016-12-19 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01875666
The ClinicalTrials.gov registry entry for NCT01875666 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01875666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01875666 about?
NCT01875666 is a clinical study titled "Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib". Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind of kinase. This study looks at a new approach to identifying kinases, which may help target therapy more precisely. LCCC1214 is a randomized, multiarm, multicenter, open-label window trial designed to explor...
What is the current status of trial NCT01875666?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2013-08-05. Estimated completion is 2016-12-19.
What interventions are being tested in trial NCT01875666?
The interventions under investigation include: Trastuzumab (DRUG), pertuzumab (DRUG), lapatinib (DRUG).
Who is sponsoring clinical trial NCT01875666?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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