Pathologic Complete Response: How can the I-SPY2 study results benefit patients with HR+ HER2- Breast Cancer? Laura Huppert MD - Synopsis below extracted from the video transcript.
Laura Huppert, MD, discusses the role of pathologic complete response (pCR) in predicting outcomes for patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. She highlights the findings from the I-SPY2 trial, a multicenter, phase 2 trial that evaluated the use of neoadjuvant therapy in this patient population.
Dr. Huppert explains that pCR, defined as the absence of residual invasive cancer in the breast and lymph nodes after neoadjuvant therapy, is a strong predictor of long-term outcomes in patients with breast cancer. However, achieving pCR has been historically difficult in HR-positive/HER2-negative breast cancer, leading to questions about the utility of this endpoint in this patient population.
The I-SPY2 trial sought to address these questions by using a novel adaptive design that allowed for the rapid evaluation of multiple experimental agents in combination with standard therapy. The trial identified biomarker signatures that predict response to therapy and allowed for the identification of patients who are more likely to achieve pCR.
Dr. Huppert notes that the I-SPY2 trial has already led to FDA approval of pertuzumab for use in combination with standard therapy in this patient population, and that ongoing analyses are likely to yield additional insights that can inform treatment decisions for HR-positive/HER2-negative breast cancer patients.
In conclusion, the I-SPY2 trial has demonstrated the feasibility of using pCR as an endpoint in HR-positive/HER2-negative breast cancer and has provided valuable insights into the biology of this disease. Further research is needed to refine the use of this endpoint and to identify optimal treatment strategies for this patient population.
