A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer

Sponsor
Henan Cancer Hospital
Study ID
NCT07540533
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

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

Interventions

  • Toripalimab — DRUG
    Toripalimab
  • TPC — DRUG
    Treatment of Physician's Choice

Study Details

To evaluate the efficacy and safety of toripalimab in combination with investigator-selected chemotherapy in patients with recurrent or metastatic HER2-negative breast cancer who have failed prior systemic therapy.

Key Dates

First listed
Apr 20, 2026
Start date
Jan 20, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
92 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Cohort A: triple-negative breast cancer (TNBC) previously treated with immune-checkpoint inhibitors (ICI);
  • Experimental: Cohort B
    Cohort B: TNBC without prior ICI exposure;
  • Experimental: Cohort C
    Cohort C: HR-positive/HER2-negative breast cancer.

Primary Outcome Measure

ORR by investigator [ Time Frame: At baseline, at the time point of every 8 weeks within first 24 weeks, thereafter every 12 weeks ]

Central Contacts

  • Min Yan, Chief physician
    +86-15713857388
    [email protected]
  • Meng wei Zhang, Associate Chief Physician

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