Pyrotinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer: Phase II PERMEATE Trial

By: Kayci Reyer
Posted: Monday, May 9, 2022

According to research presented in The Lancet Oncology, a combination treatment of the tyrosine kinase inhibitor pyrotinib plus capecitabine may be efficacious and tolerable in patients with HER2-positive breast cancer that has metastasized to the brain. PERMEATE, a phase II, multicenter trial performed in China, is reported to be the first prospective study analyzing this treatment combination among this patient population.

“This combination deserves further validation in a [randomized], controlled trial,” concluded Min Yan, MD, of the Henan Breast Cancer Centre in China, and colleagues.

Between January 29, 2019, and July 10, 2020, the study enrolled 78 women. Patients who had HER2-positive brain metastases who had not been treated with radiotherapy entered cohort A (n = 59), and patients who had experienced disease progression following radiation therapy entered cohort B (n = 19). All patients received 400 mg of daily oral pyrotinib plus 1,000 mg/m² of twice-daily oral capecitabine for 14 days with a subsequent 7-day treatment-free period. Treatment ended after disease progression or unacceptable toxicity occurred.

At a median follow-up of 15.7 months, cohort A experienced a superior intracranial objective response rate versus cohort B (74.6% vs. 42.1%). Diarrhea was the most commonly occurring treatment-emergent adverse event, occurring in 14 patients in cohort A and 4 patients in cohort B. Serious treatment-related adverse events were reported in two patients in cohort A and three patients in cohort B.

Disclosure: For full disclosures of the study authors, visit thelancet.com.

The Lancet Oncology

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