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NCT01772472 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,486
- Enrollment target
NCT01772472 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,486 participants.
The verdict
NCT01772472, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,486 participants
- Enrollment target
Study Summary
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
Interventions
- DRUG trastuzumab
- DRUG trastuzumab emtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,486 participants |
| Start Date | 2013-04-03 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01772472
The ClinicalTrials.gov registry entry for NCT01772472 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which trastuzumab is the first listed.
NCT01772472 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01772472 about?
NCT01772472 is a clinical study titled "A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)". This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible p...
What is the current status of trial NCT01772472?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,486 participants. The study started on 2013-04-03. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT01772472?
The interventions under investigation include: trastuzumab (DRUG), trastuzumab emtansine (DRUG).
Who is sponsoring clinical trial NCT01772472?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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