A Randomized, Open-label, Multicenter Phase III Clinical Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Breast Cancer Who Have Previously Failed Endocrine Therapy
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.
• Aged ≥ 18 and ≤ 75 years at the time of signing the ICF, male or female;
• Histologically and/or cytologically confirmed HR+/HER2- BC based on pathological reports from the most recent biopsy or other pathological specimens;
• Subjects must have radiologically documented disease progression during or after the most recent treatment prior to enrollment;
• No prior systemic chemotherapy for locally advanced, relapsed, or metastatic stages. Subjects who previously received adjuvant/neoadjuvant chemotherapy and progressed \>6 months after completion of the last chemotherapy treatment will be allowed for study inclusion;
• The investigator assessed that the patient could not continue to benefit from endocrine therapy and was suitable for receiving first-line chemotherapy;
• Able to provide recently newly obtained or archival tumor tissue sections at or after diagnosis of relapsed or metastatic tumor within the recent prior to randomization;
• At least one measurable lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;
• Life expectancy of ≥ 12 weeks;
⁃ Suitable to receive one of the chemotherapy regimens listed in the investigator's choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine) as assessed by the investigator;
⁃ Adequate organ and bone marrow function;
⁃ Having recovered from all toxicities due to prior treatment;
⁃ Use of effective medical contraception during study treatment and for 6 months after the end of dosing for female subjects of childbearing potential and male subjects with partners of childbearing potential;
⁃ Willingness to participate in the study, sign the ICF, and comply with the protocol-specified visits and relevant procedures.