A Phase II Study of Triple-negative Breast Cancer Brain Metastases.

Sponsor
Fudan University
Study ID
NCT04303988
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1316 — DRUG
    IV
  • Bevacizumab — DRUG
    IV
  • Cisplatin/Carboplatin — DRUG
    IV

Study Details

Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases.

Key Dates

First listed
Mar 11, 2020
Start date
Mar 30, 2020
Status verified
Jul 2024
Primary completion
Dec 30, 2024
Completion
May 30, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort HR-/HER2-
    Hormone receptor negative, HER2 negative participants will receive SHR1316 in combination with bevacizumab plus cisplatin or carboplatin until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Primary Outcome Measure

Overall Response Rate in the CNS [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 24 months ]

Central Contacts

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