Table 9 Main remaining points of controversy and what additional data is needed to clarify them
Points of controversy | What additional data is needed? |
|---|---|
Diagnosis and treatment of HER2-negative tumors and low-ER immunohistochemical expression (1-10%). | - Advancement and standardization of immunohistochemistry analysis. - Prospective studies evaluating the difference in treatment and oncological outcomes. |
Treatment of ER+/HER2- tumors with a gene signature suggestive of the basal-like subtype. | - Expanding access to molecular tests. - Prospective studies evaluating the difference in treatment and oncological outcomes. |
Axillary surgery for patients with initially cN+ and complete clinical response following NAT. | - Is the marking of the compromised lymph node essential (prior to NAT)? - Does the increase in the false negative rate affect the recurrence rate or overall survival? - New randomized studies evaluating clinical outcomes according to different surgical strategies. |
Combination of capecitabine and pembrolizumab in patients with wild-type BRCA who had received NAT and had residual disease. | - New studies evaluating the efficacy and safety of this combination in the adjuvant setting. |
Combination of olaparib and immunotherapy for women with the BRCA mutation who achieved pCR following NAT. | - New studies evaluating the efficacy and safety of this combination in the adjuvant setting. |