GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer

Clinical symptomatic brain metastasis is defined as untreated and symptomatic, or requiring steroid or anticonvulsant treatment to control related symptoms. Patients with asymptomatic brain metastasis, or with stable clinical symptoms and no need for steroid hormone and other treatments for brain metastasis for ≥28 days, can be enrolled.

During (neo)adjuvant therapy, received pyrotinib, and the participants who have experienced recurrence or metastasis more than 6 months after the last treatment and have not received pirlotinib since then are allowed to be enrolled;

Participants who have received pirlotinib treatment during the recurrent and metastatic stage, discontinued the medication due to reasons other than disease progression, and have progressed more than 6 months after discontinuation are allowed to be enrolled;

Participants who have received treatment with ADC drugs with different small molecule toxins (such as DS-8201, GQ1005, SHR-A1811, etc.) are eligible for enrollment. Such patients are also allowed to have received pirlotinib treatment during the recurrent or metastatic stage, and those who have progressed after more than 6 months of pirlotinib treatment are also eligible for enrollment.