Hi @lling
The guidance is not clear on what indications fall under ICHS9 and how to classify drugs which are indicated for both early and advanced cancers. However, breast cancer is not being considered as advanced cancer. There are several cases where regulators have not approved nitrosamine specs based on ICH Q3 for breast cancer. Please find link on further discussions on this topic Novartis pauses some trials of cancer drug Kisqali to fix manufacturing