Perjeta (pertuzumab)

18F-FDG PET-CT before and after the first cycle of neoadjuvant treatment does not appear to be an effective tool to predict pCR in patients with HER2+ BC.

The efficacy of NAT regimens containing trastuzumab plus pertuzumab (HP) and trastuzumab plus pyrotinib (HPy) was compared. Both HP and HPy combined with chemotherapy can be considered as optional NAT regimens for HER2-positive BC. The nomogram incorporating common clinical indicators provides a basis for clinicians to predict NAT efficacy at an earlier stage.

P1, N=0, Withdrawn, Beijing Bio-Targeting Therapeutics Technology Co., Ltd | N=27 --> 0 | Enrolling by invitation --> Withdrawn

P2, N=33, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | N=185 --> 33 | Trial completion date: Feb 2026 --> Dec 2024 | Recruiting --> Terminated; Abandon of the partner, ROCHE

These results support ipatasertib plus HP as a safe and promising maintenance strategy for HER2-positive breast tumors harboring PIK3CAmut.

P1/2, N=210, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Oct 2026 --> Jul 2026 | Trial primary completion date: Oct 2025 --> Jul 2026

P=N/A, N=50, Active, not recruiting, Nagoya City University | Enrolling by invitation --> Active, not recruiting

P3, N=1560, Active, not recruiting, Fudan University | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Jul 2027 | Trial primary completion date: Jul 2021 --> Jul 2026

She received neoadjuvant chemotherapy combined with dual anti-HER2 therapy (trastuzumab and pertuzumab), followed by a right mastectomy with axillary lymph node dissection, locoregional conformal radiotherapy, and stereotactic radiotherapy to the L5 lesion. A complete response, both histological and metabolic, was achieved and has been sustained after two years of follow-up. This case underscores the value of a personalized, multimodal treatment approach.

P2, N=188, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

While HER2-targeted therapies such as trastuzumab and pertuzumab have improved clinical outcomes, resistance, particularly to trastuzumab, remains a major therapeutic challenge. Structural modeling suggests that both bpAbs engage HER2 in a trans-binding mode, leading to receptor clustering and interference with ligand-driven HER2 heterodimerization. These findings demonstrate that epitope-guided biparatopic antibody design can enhance HER2 downregulation and restore sensitivity to HER2-targeted therapy in vitro, providing a strategy for the development of next-generation receptor-targeted biologics.

Among the 161 patients receiving neoadjuvant trastuzumab-pertuzumab therapy, 81 achieved pCR (50.31%), while 80 did not (49.69%). However, multivariate logistic regression confirmed Her-2 expression as the sole independent predictor: Her-2 (3+) patients had significantly higher pCR rates than Her-2 (2+)/FISH(+) cases (p=0.005; OR: 0.170 [95% CI: 0.045-0.639]). Her-2 (3+) expression correlates with superior pCR rates, underscoring the need for further research to refine patient selection for optimized targeted therapy benefits.