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NCT01966471 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,846
- Enrollment target
NCT01966471 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,846 participants.
The verdict
NCT01966471, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,846 participants
- Enrollment target
Study Summary
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Pertuzumab
- DRUG Trastuzumab Emtansine
- DRUG Epirubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,846 participants |
| Start Date | 2014-01-31 |
| Est. Completion | 2021-06-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01966471
The ClinicalTrials.gov registry entry for NCT01966471 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,846 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 5 interventions - of which Trastuzumab is the first listed.
NCT01966471 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01966471 about?
NCT01966471 is a clinical study titled "A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer". This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-p...
What is the current status of trial NCT01966471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,846 participants. The study started on 2014-01-31. Estimated completion is 2021-06-04.
What interventions are being tested in trial NCT01966471?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Pertuzumab (DRUG), Trastuzumab Emtansine (DRUG), Epirubicin (DRUG).
Who is sponsoring clinical trial NCT01966471?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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