Clinical trial · no report yet · Phase 3
FeDeriCa
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
- NCT03493854 ↗
- Completed
- Hoffmann-La Roche
- 9 commentary sources found
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| YouTube | 6 | |
| Podcasts | 2 | |
| X threads | 1 |
The trial
ClinicalTrials.gov- Official title
- A Phase III, Randomized, Multicenter, Open-Label, Two-Arm 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 Patients With HER2-Positive Early Breast Cancer
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Early Breast Cancer
- Interventions
- Cyclophosphamide; Doxorubicin; Docetaxel; Paclitaxel; Pertuzumab IV; FDC of Pertuzumab and Trastuzumab SC; Trastuzumab IV; Trastuzumab SC; Surgery; Post-operative Radiotherapy; Hormone Therapy
- Arms
- Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy · Active comparator
- Arm B: FDC of Pertuzumab and Trastuzumab SC + Chemotherapy · Experimental
- Enrollment
- 500
- Primary outcomes
- Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8)
- Sponsor
- Hoffmann-La Roche
- Start
- Jun 14, 2018
- Primary completion
- Jul 4, 2019
- Results posted
- Yes
- Registry record
- NCT03493854 · updated Jun 26, 2024
Publications
linked from the registry- Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21. PubMed 33357420