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NCT00524303 · ClinicalTrials.gov registry record · Phase 2
Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00524303: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00524303 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00524303, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.
Primary Outcome
A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ \[DCIS\] or lobular carcinoma in situ \[LCIS\] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of trea
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Lapatinib
- DRUG FEC75
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2007-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT00524303 record still lists
NCT00524303 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT00524303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00524303 about?
NCT00524303 is a clinical study titled "Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.". This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.
What is the current status of trial NCT00524303?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2007-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00524303?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Lapatinib (DRUG), FEC75 (DRUG).
Who is sponsoring clinical trial NCT00524303?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00524303's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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