JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study ID
NCT06079983
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • JSKN003 — DRUG
    Administered intravenously according to protocol.
  • Capecitabine tablets — DRUG
    Administered according to protocol, as one option for investigator's choice (determined before randomization).
  • Gemcitabine hydrochloride for injection — DRUG
    Administered according to protocol, as one option for investigator's choice (determined before randomization).
  • Vinorelbine tartrate injection — DRUG
    Administered according to protocol, as one option for investigator's choice (determined before randomization).
  • Paclitaxel for injection (albumin-bound type) — DRUG
    Administered according to protocol, as one option for investigator's choice (determined before randomization).
  • Docetaxel injection — DRUG
    Administered according to protocol, as one option for investigator's choice (determined before randomization).
  • Eribulin mesylate injection — DRUG
    Administered according to protocol, as one option for investigator's choice (determined before randomization).

Study Details

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy. The study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to: * Experimental group: JSKN003 monotherapy * Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

Key Dates

Start date
Dec 1, 2023
Status verified
Sep 2025
Primary completion
Apr 1, 2026
Completion
Mar 1, 2029

Study Design

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

Arms

  • Experimental: JSKN003
    Administered intravenously according to protocol.
  • Active Comparator: The chemotherapy chosen by the investigator
    The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: up to approximately 3 years after the first enrollment ]

Central Contacts

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