Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Lapatinib and Trastuzumab With or Without Endocrine Therapy
NCT00548184 · View on ClinicalTrials.gov ↗
Study Summary
We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors. The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Lapatinib
- DRUG Endocrine
Study Locations (6)
Alabama
- UAB Cancer Center — Birmingham
Illinois
- The University of Chicago — Chicago
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bunting-Blaustein Cancer Research — Baltimore
Minnesota
- Mayo Clinic Cancer Center — Rochester
Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville
Texas
- Baylor College of Medicine, Lester and Sue Smith Breast Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2008-05 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00548184
The ClinicalTrials.gov registry entry for NCT00548184 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Breast Care Center, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00548184 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Alabama, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00548184 about?
NCT00548184 is a clinical study titled "Lapatinib and Trastuzumab With or Without Endocrine Therapy". We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib pl...
What is the current status of trial NCT00548184?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2008-05. Estimated completion is 2014-01.
What conditions does trial NCT00548184 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00548184?
The interventions under investigation include: Trastuzumab (DRUG), Lapatinib (DRUG), Endocrine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00548184?
This trial is sponsored by Baylor Breast Care Center, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00548184 being conducted?
This trial has 6 study locations across Alabama, Illinois, Maryland, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.