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NCT02297230 · ClinicalTrials.gov registry record · Phase 1
Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics
A Phase 1 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT02297230 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 44 participants.
The verdict
NCT02297230, a Phase 1 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total. \*\*Surgery: Patients will undergo lumpectomy and axillary node dissection or modified radical mastectomy within two months following discontinuation of pre-operative systemic therapy, contingent upon recovery of skin toxicity. Pathologic response will be evaluated at the time of surgery. Additional tissue samples will be collected from the surgical specimen for assessment of tumor molecular characteristics. \*\*\*All patients may undergo four cycles of post-operative Standard AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) or four cycles of post-operative epirubicin and Cyclophosphamide (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) if doxorubicin is not available Tamoxifen as well or any alternative antihormonal therapy may be prescribed for five years for patients with hormone receptor positive tumors. Herceptin (Trastuzumab) will be prescribed for a total of 1 year since first dose as per standard of care.
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Paclitaxel
- RADIATION Radiation Therapy (RT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2002-06 |
| Est. Completion | 2014-12-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02297230
The ClinicalTrials.gov registry entry for NCT02297230 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT02297230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02297230 about?
NCT02297230 is a clinical study titled "Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics". Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end o...
What is the current status of trial NCT02297230?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2002-06. Estimated completion is 2014-12-02.
What interventions are being tested in trial NCT02297230?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Radiation Therapy (RT) (RADIATION).
Who is sponsoring clinical trial NCT02297230?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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