A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/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.

Trial Details

NCT ID
NCT07071337
Phase
PHASE3
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • SKB264
  • Nab-paclitaxel
  • Paclitaxel
  • Capecitabine
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • 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 chemothe…

For full eligibility, visit ClinicalTrials.gov.

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