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NCT00256243 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer
A Phase 2 study, sponsored by Rita Sanghvi, Mehta.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00256243: Completed Phase 2 study, sponsored by Rita Sanghvi, Mehta.
NCT00256243 is a Phase 2 study that has completed, run by Rita Sanghvi, Mehta. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256243, a Phase 2 study, has completed, sponsored by Rita Sanghvi, Mehta.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer paclitaxel and carboplatin weekly for a total of 12 doses with one week rest after every 3 weeks of treatment over 12 weeks. Patients who are her-2 over-expressors by FISH (fluorescence in situ hybridization) will also receive Trastuzumab with weekly carboplatin and paclitaxel as the combination TC±H has been found to be synergistic in advanced breast cancer with improved clinical outcome.
Primary Outcome
Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2004-04 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT00256243 record still lists
NCT00256243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00256243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256243 about?
NCT00256243 is a clinical study titled "Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer". We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer paclitaxel and carboplatin weekly for a total of 12 doses with one week rest after every 3 weeks of treatment over 12 w...
What is the current status of trial NCT00256243?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2004-04. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00256243?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00256243?
This trial is sponsored by Rita Sanghvi, Mehta, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00256243's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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