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NCT00290732 · ClinicalTrials.gov registry record · Phase 1
Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT00290732: Completed Phase 1 study of Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00290732 is a Phase 1 study of Breast Cancer that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00290732, a Phase 1 study of Breast Cancer, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given before mastectomy in treating women with invasive breast cancer.
Primary Outcome
Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.
Conditions Studied
Interventions
- DRUG Intraductal arm
- DRUG Intravenous arm
Study Locations (2)
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-11 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT00290732 record still lists
NCT00290732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Intraductal arm is the first listed.
NCT00290732 reports a single indexed study location in Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT00290732 about?
NCT00290732 is a clinical study titled "Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more tumor cells. Giving chemo...
What is the current status of trial NCT00290732?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-11. Estimated completion is 2011-10.
What conditions does trial NCT00290732 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00290732?
The interventions under investigation include: Intraductal arm (DRUG), Intravenous arm (DRUG).
Who is sponsoring clinical trial NCT00290732?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00290732 being conducted?
This trial has 2 study locations across Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT00290732's enrollment target sits among peer trials
20 1079th of 1224 higher than 112 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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