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Clinical Trial Summary

Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials. Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab. A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines. PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04644406
Study type Observational
Source Hospices Civils de Lyon
Contact Aurelie COMTE, MD
Phone +33 (0)4 78 86 43 18
Email aurelie.comte@chu-lyon.fr
Status Not yet recruiting
Phase
Start date December 2020
Completion date June 2023

See also
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Terminated NCT02154529 - Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer Phase 1/Phase 2
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Active, not recruiting NCT02947685 - Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer Phase 3
Completed NCT02066532 - Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer Phase 1/Phase 2
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Completed NCT01583426 - Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto) Phase 3
Withdrawn NCT01361945 - AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer Phase 1/Phase 2
Active, not recruiting NCT02326974 - T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA Phase 2
Terminated NCT02131506 - A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer Phase 1
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Completed NCT02488564 - A Study of Liposomal Doxorubicin + Docetaxel + Trastuzumab + Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer Phase 2
Completed NCT02492711 - Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Phase 3