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NCT01147016 · ClinicalTrials.gov registry record · Phase 2
Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01147016: Clinical Trial Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT01147016 is a Phase 2 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01147016, a Phase 2 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic complete response (pCR) rate at the time of surgery. Arming ex vivo expanded T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Giving combination neoadjuvant chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells after neoadjuvant chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.
Primary Outcome
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
Interventions
- OTHER laboratory biomarker analysis
- DRUG cyclophosphamide
- DRUG paclitaxel
- DRUG doxorubicin hydrochloride
- BIOLOGICAL HER2Bi-armed activated T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-07 |
| Est. Completion | 2017-07-26 |
| Phase | Phase 2 |
Why NCT01147016 stopped before completion
NCT01147016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01147016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01147016 about?
NCT01147016 is a clinical study titled "Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery". RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic complete response (pCR) rate at the time of surgery. Arming ex vivo expanded T cells in the laboratory may help the T ...
What is the current status of trial NCT01147016?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2010-07. Estimated completion is 2017-07-26.
What interventions are being tested in trial NCT01147016?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cyclophosphamide (DRUG), paclitaxel (DRUG), doxorubicin hydrochloride (DRUG), HER2Bi-armed activated T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01147016?
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 NCT01147016's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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