DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT06313086
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • DP303c — DRUG
    intravenous injection
  • trastuzumab emtansine — DRUG
    intravenous injection

Study Details

A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer

Key Dates

First listed
Mar 15, 2024
Start date
Mar 13, 2024
Status verified
Dec 2023
Primary completion
Dec 31, 2025
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: DP303c
    DP303c injection, 3.0 mg/kg, Q3W.
  • Active Comparator: trastuzumab emtansine
    trastuzumab emtansine,3.6 mg/kg, Q3W.

Primary Outcome Measure

Progression-free survival (PFS) by BIRC [ Time Frame: Up to approximately 4 years ]

Central Contacts

Find similar trials

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials

Related Studies