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NCT00616967 · ClinicalTrials.gov registry record · Phase 2
Carboplatin and Nab-Paclitaxel With or Without Vorinostat in Treating Women With Newly Diagnosed Operable Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 5
- Study locations
NCT00616967: Active Phase 2 study of Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00616967 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 68 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616967, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 5
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in treating women with breast cancer that can be removed by surgery.
Primary Outcome
The primary end point was pCR, defined as no viable invasive cancer in breast and axilla. All other cases were defined as non-pCR. The pCR rate was determined in each arm separately by performing an intent-to-treat (ITT) analysis of all randomized patients. Patients with unknown pCR status were considered non-responders. Computation of associated 90% confidence intervals did not account for the sequential design.
Conditions Studied
Interventions
- OTHER placebo
- DRUG carboplatin
- DRUG vorinostat
- DRUG paclitaxel albumin-stabilized nanoparticle formulation
Study Locations (5)
Maryland
- Anne Arundel Health System - Annapolis
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Alabama
- University of Alabama Comprehensive Cancer Center - Birmingham
Indiana
- Indiana University Purdue University of Indianapolis - Indianapolis
Minnesota
- Mayo Clinic Cancer Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2008-05 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
What the registry record for NCT00616967 still lists
NCT00616967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 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 4 interventions - of which placebo is the first listed.
NCT00616967 lists 5 locations in 4 states (Maryland, Alabama, Indiana).
Frequently Asked Questions
What is clinical trial NCT00616967 about?
NCT00616967 is a clinical study titled "Carboplatin and Nab-Paclitaxel With or Without Vorinostat in Treating Women With Newly Diagnosed Operable Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking so...
What is the current status of trial NCT00616967?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2008-05. Estimated completion is 2027-02.
What conditions does trial NCT00616967 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00616967?
The interventions under investigation include: placebo (OTHER), carboplatin (DRUG), vorinostat (DRUG), paclitaxel albumin-stabilized nanoparticle formulation (DRUG).
Who is sponsoring clinical trial NCT00616967?
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 NCT00616967 being conducted?
This trial has 5 study locations across Alabama, Indiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00616967's enrollment target sits among peer trials
68 706th of 1224 higher than 509 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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