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NCT03493854 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
NCT03493854 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 500 participants.
The verdict
NCT03493854, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
Study Summary
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.
Interventions
- DRUG Cyclophosphamide
- DRUG Docetaxel
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Pertuzumab IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2023-06-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03493854
The ClinicalTrials.gov registry entry for NCT03493854 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 500 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 Cyclophosphamide is the first listed.
NCT03493854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03493854 about?
NCT03493854 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer". This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epid...
What is the current status of trial NCT03493854?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2018-06-14. Estimated completion is 2023-06-02.
What interventions are being tested in trial NCT03493854?
The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Pertuzumab IV (DRUG).
Who is sponsoring clinical trial NCT03493854?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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