DP303c in Patients With HER2-positive Advanced Breast Cancer

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT05901935
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • HER2-positive Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DP303c — DRUG
    DP303c injection, 3.0 mg/kg, Q3W.
  • Trastuzumab — DRUG
    IV, 6 mg/kg, D1, Q3W
  • Vinorelbine Tartrate — DRUG
    IV, 25 mg/m\^2，D1、D8，Q3W
  • Capecitabine tablets — DRUG
    PO 1000 mg/m\^2, bid, D1-D14, Q3W

Study Details

This is a study of DP303c in patients with HER2-positive advanced breast cancer.

Key Dates

Start date
Jul 31, 2023
Status verified
May 2023
Primary completion
Jan 31, 2026
Completion
Jul 31, 2028

Study Design

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

Arms

  • Experimental: DP303c
    Eligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks.
  • Active Comparator: Trastuzumab combined with vinorelbine/capecitabine
    Eligible patients will be treated with trastuzumab IV on day 1 and oral capecitabine twice daily on days 1-14 every 3 weeks, or patients will be treated with trastuzumab IV on day 1 and vinorelbine IV over on days 1 and 8 every 3 weeks.

Primary Outcome Measure

Progression-free survival (PFS) by BIRC [ Time Frame: Up to approximately 5 years ]

Central Contacts

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