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NCT00548184 · ClinicalTrials.gov registry record · Phase 2
Lapatinib and Trastuzumab With or Without Endocrine Therapy
A Phase 2 study of Breast Cancer, sponsored by Baylor Breast Care Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 6
- Study locations
NCT00548184: Completed Phase 2 study of Breast Cancer, sponsored by Baylor Breast Care Center.
NCT00548184 is a Phase 2 study of Breast Cancer that has completed, run by Baylor Breast Care Center. The registered enrollment target is 65 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00548184, a Phase 2 study of Breast Cancer, has completed, sponsored by Baylor Breast Care Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.
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 |
What the finished NCT00548184 record still lists
NCT00548184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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.
NCT00548184 lists 6 locations in 6 states (Alabama, Illinois, Maryland).
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.
What interventions are being tested in trial NCT00548184?
The interventions under investigation include: Trastuzumab (DRUG), Lapatinib (DRUG), Endocrine (DRUG).
Who is sponsoring clinical trial NCT00548184?
This trial is sponsored by Baylor Breast Care Center, which has 15 total clinical trials registered on ClinicalTrials.gov.
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
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00548184's enrollment target sits among peer trials
65 722nd of 1224 higher than 501 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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