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NCT00331630 · ClinicalTrials.gov registry record · Early Phase 1
Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
A Early Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT00331630: Completed Early Phase 1 study, sponsored by Northwestern University.
NCT00331630 is a Early Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00331630, a Early Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I, stage II, or stage III breast cancer.
Primary Outcome
cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)\>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline s
Interventions
- DRUG paclitaxel albumin-stabilized nanoparticle formulation
- DRUG lapatinib ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-05-04 |
| Est. Completion | 2010-08-05 |
| Phase | Early Phase 1 |
What the finished NCT00331630 record still lists
NCT00331630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which paclitaxel albumin-stabilized nanoparticle formulation is the first listed.
NCT00331630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00331630 about?
NCT00331630 is a clinical study titled "Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane toge...
What is the current status of trial NCT00331630?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2006-05-04. Estimated completion is 2010-08-05.
What interventions are being tested in trial NCT00331630?
The interventions under investigation include: paclitaxel albumin-stabilized nanoparticle formulation (DRUG), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT00331630?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00331630's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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