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NCT03674112 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT03674112 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 160 participants.
The verdict
NCT03674112, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.
Interventions
- DRUG Pertuzumab IV
- DRUG Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
- DRUG Trastuzumab IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2018-12-19 |
| Est. Completion | 2022-10-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03674112
The ClinicalTrials.gov registry entry for NCT03674112 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 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 3 interventions - of which Pertuzumab IV is the first listed.
NCT03674112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03674112 about?
NCT03674112 is a clinical study titled "A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer". This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early b...
What is the current status of trial NCT03674112?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2018-12-19. Estimated completion is 2022-10-12.
What interventions are being tested in trial NCT03674112?
The interventions under investigation include: Pertuzumab IV (DRUG), Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC) (DRUG), Trastuzumab IV (DRUG).
Who is sponsoring clinical trial NCT03674112?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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