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NCT01075100 · ClinicalTrials.gov registry record · Phase 2
Ixabepilone + Carboplatin Metastatic Breast Cancer
A Phase 2 study, sponsored by US Oncology Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT01075100: Completed Phase 2 study, sponsored by US Oncology Research.
NCT01075100 is a Phase 2 study that has completed, run by US Oncology Research. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01075100, a Phase 2 study, has completed, sponsored by US Oncology Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination with gemcitabine or paclitaxel has activity in metastatic breast cancer (MBC); there is also demonstrated activity of the gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this combination at the doses and schedule proposed for this Phase II trial (BMS data on file).
Primary Outcome
Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive \[ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-\]) and ER-/PR-HER2-, separately). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions;
Interventions
- DRUG Carboplatin
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01075100 record still lists
NCT01075100 is an interventional study that assigns participants to a tested intervention. The registered 103 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 (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT01075100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01075100 about?
NCT01075100 is a clinical study titled "Ixabepilone + Carboplatin Metastatic Breast Cancer". Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination wi...
What is the current status of trial NCT01075100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2010-01. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01075100?
The interventions under investigation include: Carboplatin (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT01075100?
This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01075100's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 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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