Perjeta (pertuzumab)

P2, N=702, Recruiting, West German Study Group | Active, not recruiting --> Recruiting | N=402 --> 702 | Trial completion date: Jun 2029 --> Sep 2030 | Trial primary completion date: Jun 2025 --> Jun 2030

Given the clinical severity, inpatient treatment was promptly initiated with trastuzumab and pertuzumab every three weeks, combined with weekly paclitaxel at a 50% dose reduction. In carefully selected patients, early and sustained HER2-directed therapy can lead to meaningful clinical recovery when options appear limited. Such cases help bridge the evidence gap for this high-risk group and may inform future therapeutic considerations.

She received six cycles of neoadjuvant docetaxel, carboplatin, trastuzumab, and pertuzumab. Persistent radiologic abnormalities may represent residual mucin rather than viable tumor cells, underscoring a potential limitation of imaging-based response evaluation. This report provides insight into response interpretation in this rare entity and supports the need for cautious clinical decision-making.

Methods We derived a novel PDX from a patient with hormone receptor negative, HER2-positive IBC refractory to neoadjuvant chemotherapy with Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP)...We performed short-tandem repeat (STR) profiling, plotted tumor growth curves for mice treated with alpelisib/everolimus vs. untreated, and immunohistochemistry (IHC), and performed clinical genomic assays...Conclusion We established a PDX of a HER2-positive IBC tumor with a PIK3CA hotspot mutation (H1047R) refractory to TCHP. Targeting the PI3K/mTOR pathway may be useful to overcome resistance in HER2-positive IBC with a H1047R mutation in PIK3CA.

P3, N=596, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

Patient characteristics reflect current Chinese practice. Increasing adoption of diarrhoea prophylaxis in real-world practice reflects growing clinical experience with neratinib and its recognised benefit in preventing diarrhoea.

PH FDC SC was associated with significant time savings for both patients and healthcare providers. The transition to SC administration unlocked 2468.25 clinical hours annually, translating into notable indirect cost reductions through optimized resource utilization and improved operational efficiency compared with IV administration.

P2, N=100, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University

P2, N=45, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University

This phase II study showed that neoadjuvant chemotherapy with T + scH resulted in pCR of 53%, surpassing the planned cutoff for success of 40%. This is comparable with the rates and other efficacy end points that follow data from phase II international trials. This regimen may be useful in the absence of pertuzumab and warrants further investigation.

In a real-world setting, anthracycline-free neoadjuvant chemotherapy with dual HER2 blockade achieved pCR rates comparable to anthracycline-containing regimens with acceptable toxicity and preserved cardiac safety, suggesting that it may be a reasonable treatment option for selected patients.

P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Dec 2027