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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01966471 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,846 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (139% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evide
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 |
What the finished NCT01966471 record still lists
NCT01966471 is an interventional study that assigns participants to a tested intervention. Its 1,846 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 (139% higher).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT01966471 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01966471's enrollment target sits among peer trials
1,846 114th of 2000 higher than 1,887 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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