NCT04644406

PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER-2 Positive Breast Cancer

Interventions

Type	Name	Description
OTHER	Efficacy of the Pertuzumab-Trastuzumab combination	The efficacy of the pertuzumab in combination with one of the biosimilars of Trastuzumab will be estimated by measuring the PFS at 6 months after the beginning of the treatment.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2020-11-25
• Last updated: 2020-11-25

Locations

6 sites across 1 country: France