A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

Summary

This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

Timeline

Start

2018-12-19

Primary completion

2020-02-24

Completion

2022-10-12

Outcome

Met primary endpoint

release “PHranceSCa study showed that 85% of patients (N=136/160) evaluated in the study preferred RG6264 injection” chugai-pharm.co.jp ↗

Publications

• O'Shaughnessy J, Sousa S, Cruz J, Fallowfield DL, Auvinen P, Pulido C, Cvetanovic A, Wilks S, Ribeiro L, Burotto M, Boulet T, Revelant V, Theron N, Trask P, Wahyudi L, Kirchmayer Machackova Z, Stamatovic L. Long-Term Safety and Efficacy of the Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-Positive Early Breast Cancer in PHranceSCa, a Randomized, Open-Label Phase II Study. Clin Breast Cancer. 2025 Aug;25(6):554-559.e1. doi: 10.1016/j.clbc.2025.04.016. Epub 2025 May 3.
• O'Shaughnessy J, Sousa S, Cruz J, Fallowfield L, Auvinen P, Pulido C, Cvetanovic A, Wilks S, Ribeiro L, Burotto M, Klingbiel D, Messeri D, Alexandrou A, Trask P, Fredriksson J, Machackova Z, Stamatovic L; PHranceSCa study group. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. Eur J Cancer. 2021 Jul;152:223-232. doi: 10.1016/j.ejca.2021.03.047. Epub 2021 Jun 16.

Drugs

Indications