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NCT01022138 · ClinicalTrials.gov registry record · Phase 2
Laboratory-Treated T Cells After Second-Line Chemotherapy in Treating Patients With HER2/Neu-Negative Metastatic Breast Cancer
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT01022138: Clinical Trial Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT01022138 is a Phase 2 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01022138, a Phase 2 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Giving laboratory-treated T cells after chemotherapy may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well giving laboratory-treated T cells after second-line chemotherapy works in treating patients with HER2/neu-negative metastatic breast cancer.
Primary Outcome
26 evaluable patients will be accrued in this study. A single-arm, single-stage phase II design will be used. If ≥9 out of 26 patients have not progressed by the 4-month follow-up, we will declare that the treatment is effective on TTP.
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory biomarker analysis
- BIOLOGICAL HER2Bi-armed activated T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-03-08 |
| Est. Completion | 2019-02-19 |
| Phase | Phase 2 |
Why NCT01022138 stopped before completion
NCT01022138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01022138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01022138 about?
NCT01022138 is a clinical study titled "Laboratory-Treated T Cells After Second-Line Chemotherapy in Treating Patients With HER2/Neu-Negative Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Giving laborato...
What is the current status of trial NCT01022138?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2010-03-08. Estimated completion is 2019-02-19.
What interventions are being tested in trial NCT01022138?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory biomarker analysis (OTHER), HER2Bi-armed activated T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01022138?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01022138's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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