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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01772472 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,486 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the
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 |
What the finished NCT01772472 record still lists
NCT01772472 is an interventional study that assigns participants to a tested intervention. Its 1,486 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 2 interventions - of which trastuzumab is the first listed.
NCT01772472 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01772472's enrollment target sits among peer trials
1,486 163rd of 2000 higher than 1,838 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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