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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03493854 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, particip
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 |
What the finished NCT03493854 record still lists
NCT03493854 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03493854 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03493854's enrollment target sits among peer trials
500 744th of 2000 higher than 1,226 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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