A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
• Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
• HR-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy.
• Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
• Has documented radiologic progression (during or after most recent treatment).
• Has at least 1 protocol-defined measurable lesion.
• Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions.
• Fertile women (WOCBP) subjects agreed to use highly effective contraception and not to breastfeed from the time of study screening until 7 months after receiving the last study medication; a fertile woman must have a negative serum pregnancy test result within 7 days prior to the first treatment.