Barbara Jane O’Brien, MD, affiliate professor, Neuro-Oncology, Division of Neuro-Oncology, Division of Most cancers Drugs, The College of Texas MD Anderson Most cancers Heart, discusses the significance of increasing scientific trial enrollment standards to incorporate sufferers with HER2-positive breast most cancers with mind metastases.
Traditionally, sufferers with HER2-positive breast most cancers who’ve mind metastases, together with leptomeningeal metastases, have been excluded from many breast most cancers scientific trials, O’Brien begins. These sufferers comprise a singular subgroup with wants, response patterns, and remedy outcomes which can be distinct from these of sufferers with out mind metastases, O’Brien says. Nevertheless, sooner or later, sufferers with breast most cancers mind metastases needs to be included in additional scientific trials, O’Brien emphasizes. The part 2 HER2CLIMB trial (NCT02614794) is a first-rate instance of a examine that efficiently evaluated an efficient remedy possibility for sufferers with illness involvement within the central nervous system, O’Brien notes. Findings from this examine supported the 2020 FDA approval of tucatinib (Tukysa) plus trastuzumab (Herceptin) and capecitabine (Xeloda) for the remedy of pretreated grownup sufferers with superior unresectable or metastatic HER2-positive breast most cancers, together with these with mind metastases. Hopefully, future scientific trials in breast most cancers will enroll cohorts of sufferers with leptomeningeal metastases or solely consider therapies on this affected person inhabitants, O’Brien concludes.
On the 2024 ASCO Annual Assembly, O’Brien offered findings from the part 2 TBCRC049 trial (NCT03501979), which investigated tucatinib plus trastuzumab and capecitabine in sufferers with HER2-positive breast most cancers with leptomeningeal metastases. This trial enrolled 17 sufferers, all of whom had mind MRI proof of leptomeningeal metastases. Eighty-two % of sufferers additionally had mind metastases, and 65 of sufferers had obtained remedy for mind metastases. All 13 response-evaluable sufferers achieved scientific profit with the routine, and 5 achieved goal responses of their leptomeningeal metastases. Moreover, 7 of 12 evaluable sufferers with goal deficits at baseline had improved deficits with the remedy.
