This is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer.
Age ≥18 years.
Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification).
ECOG performance status 0-2.
Estimated life expectancy >12 weeks.
Prior or current exposure to antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor, including but not limited to fam-trastuzumab deruxtecan (DS-8201a).
Active brain metastases or leptomeningeal metastases (patients with asymptomatic/inactive brain metastases are allowed to be enrolled);
Other malignancy diagnosed within 5 years prior to enrollment, excluding cured non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ, or stage I grade 1 endometrial cancer;
Radiotherapy, any anti-HER2 targeted therapy, or chemotherapy within 4 weeks prior to enrollment; endocrine therapy within 2 weeks prior to enrollment;
Parallel
SHR-A1811
Drug4.8 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
Pyrotinib
Drug400 mg, administered orally once daily, continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
Capecitabine
Drug1000mg/m2, administered orally twice daily on Days 1-14, with no administration on Days 15-21, 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
T-DXd
Drug5.4 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
PFS during treatment phase 1
progression free survival during treatment phase 1 : time from randomization to the first observation of tumor progression or death from any cause during treatment phase 1.
Total PFS across treatment phase 1 and treatment phase 2
Total progression free survival across treatment phase 1 and treatment phase 2: time from randomization to the second observation of tumor progression or death from any cause across treatment phase 1 and treatment phase 2.
PFS during treatment phase 2
progression free survival during treatment phase 2 : time from the first observation of tumor progression to the second observation of tumor progression or death from any cause during treatment phase 2.
ORR during treatment phase 1
Objective response rate during treatment phase 1: proportion of subjects who achieved complete response (CR) or partial response (PR) by primary tumor imaging evaluation during treatment phase 1.
DCR during treatment phase 1
Disease control rate during treatment phase 1: proportion of subjects who achieved complete response (CR) or partial response (PR) or stable disease (SD) by primary tumor imaging evaluation during treatment phase 1.
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