Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT07088263
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

Study Details

The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of advanced breast cancer progressive after standard treatment.

Key Dates

Start date
Sep 15, 2025
Status verified
Dec 2025
Primary completion
Jul 24, 2027
Completion
Jun 24, 2028

Study Design

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

Arms

  • Experimental: Chemotherapy repeated every 28 days
    Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 28 days.
  • Active Comparator: Chemotherapy repeated every 21 days
    Chemotherapy regimens, including gemcitabine, vinorelbine, eribulin, or utidelone. Gemcitabine 1000 mg/m², IV, days 1, 8; or Vinorelbine 25 mg/m², IV, days 1, 8; Vinorelbine 60-80 mg/m², Po., days 1, 8; Eribulin 1.4 mg/m², IV, days 1, 8; Utidelone 30 mg/m², IV, days 1-5; All cycles repeated every 21 days.

Primary Outcome Measure

progression-free survival (PFS) [ Time Frame: 12 months ]

Central Contacts

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