Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT06081959
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SKB264 — DRUG
    IV infusion on day 1 and Day 15 of each 28 day cycle
  • Eribulin — DRUG
    1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
  • Capecitabine — DRUG
    1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle
  • Gemcitabine — DRUG
    1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle
  • Vinorelbine — DRUG
    25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Study Details

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.

Key Dates

Start date
Oct 31, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SKB264 for injection
  • Active Comparator: Treatment of Physician's Choice
    Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.

Primary Outcome Measure

Progression-free survival (PFS) assessed by BIRC per RECIST 1.1. [ Time Frame: up to 24 months ]

Central Contacts

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