
Summary:
In recent years, several highly effective targeted agents have emerged for HER2-positive (HER2+) breast cancer, converting a breast cancer subtype that historically had the worst outcomes to the most favorable in the context of targeted agents. Recent trials have demonstrated that 10-15% of patients with metastatic HER2+ breast cancer are living for nearly a decade without their cancer growing or spreading. However, the disease is still only considered treatable versus curable. There is an increasing amount of literature that suggests that outcomes are significantly more favorable when patients are treated with consolidation therapy (treatment given after initial therapy to kill any residual cancer cells to improve the chances of a complete cure) when they have oligometastatic isease. Oligo meaning few or little. However, this approach has not been specifically studied in HER2+ breast cancer subtype. This subgroup stands to benefit the most from consolidative therapy due to the availability of highly effective HER2-directed systemic therapies.
The investigators propose that consolidative treatment may seize a critical window to eradicate resistant cancer cells that emerge during systemic therapy, resulting in a potential cure before the resistant cells spread and the development of advanced resistance mechanisms. This phase II study will assess if standard of care first-line systemic anti-HER2 therapy followed by consolidation therapy including surgery and radiotherapy to locoregional and all sites of distant disease will increase the length of time before the cancer grows or spreads in patients with newly diagnosed HER2+ breast cancer with one or two metastatic sites (de novo oligometastatic disease) compared to standard of care alone. This study is the first oligometastatic cancer trial to focus on patients with HER2+ Breast Cancer, a subset of patients who sit on the cusp of eligibility for curative treatment.
Trial Registration: ClinicalTrials.gov Identifier: NCT07053085