These first results from the ALTERNATE trial show that fewer than 2% of patients treated with 6 months of neoadjuvant endocrine therapy progressed, likely as a result of the Ki67 triaging strategy, Dr. Ma said.
“Neoadjuvant chemotherapy outcomes for patients with week 4 Ki67 over 10% will be reported later,” she said. “Genomic and biomarker correlates, as well as, importantly, relapse-free survivals are also awaited.”
An invited discussant, Antonio C. Wolff, MD, professor of oncology at Johns Hopkins University, Baltimore, said that while the co-primary endpoint of ESDR in the study was not met, the results provide “a few important messages.”
First, the study showed that low Ki67 at baseline largely stays low at 4 weeks. High Ki67 at baseline frequently became low at week 4, he said.
“Finally, we must congratulate Dr. Ma and colleagues on showing that research biopsies for integral biomarker testing can happen across the [National Clinical Trials Network] throughout the U.S., including most community sites,” he said, adding “that alone is a major accomplishment.”
Dr. Wolff also noted that the 5-year relapse-free survival data for patients who achieve mPEPI 0 at surgery are “awaited with great interest.”
The ALTERNATE trial is funded by the Alliance Foundation, NCI Biomarker, Imaging and Quality of Life Studies Funding Program, Breast Cancer Research Foundation, Genentech,and AstraZeneca. Dr. Ma reported consulting or advisory roles with a variety of pharmaceutical companies, and research funding from pharmaceutical companies to her institution. Dr. Wolff reported relationships (consulting or advisory roles and research funding) with Ionis, Biomarin, Celldex, and patents or royalties (issued or pending) associated with methylation in breast cancer.
SOURCE: Ma C et al. ASCO 2020: Abstract 504.