Clinical Trial

Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer

Study acronym: PHERGAIN-2
Active, Not Recruiting Phase 2
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Summary
This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous fixed-dose combination) and T-DM1, for patients with previously untreated HER2-positive early breast cancer.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2021-01-29; most recent amendment 2026-04-24.
Status change: Recruiting → Active, Not Recruiting 2024-03-12
Status change: Not Yet Recruiting → Recruiting 2022-03-23
Trial Details
NCT Number NCT04733118
Lead Sponsor MedSIR
Collaborators: Hoffmann-La Roche
Conditions Early Breast Cancer
Enrollment 393 participants
Start Date 2021-08-05
Primary Completion 2027-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-29