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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 is a Phase 2 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01147016
The ClinicalTrials.gov registry entry for NCT01147016 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01147016 reports 0 study locations.
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.
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