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;
Subjects with locally advanced breast cancer suitable for curative therapy at study enrollment;
Other malignancies (except those tumors cured by local treatment, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of the cervix) within 3 years prior to randomization;
Subiects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression or active centralnervous system (CNS) metastases.
Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors;
Parallel
SKB264
Drug5mg/kg, IV on Day 1 and Day 15 of each 28 day cycle
Nab-paclitaxel
Drug100 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks
Paclitaxel
Drug90 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks; or 80 mg/m\^2, IV, weekly, every 3 weeks
Capecitabine
Drug1000-1250 mg/m\^2, orally, Days 1-14, twice daily, every 3 weeks
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause
Progression-Free Survival (PFS) assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1
Disease control rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1
Click on the lead sponsor to view all of their trials.
