A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

Primary Endpoint of this Study:

To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \[BIRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).

To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.

Eligibility criteria

Qualifiers

Voluntarily sign the Informed Consent Form (ICF).

Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Life expectancy ≥ 3 months.

Disqualifiers

Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC), with the exception of TROP2-targeted ADCs.

Diagnosis of another malignancy within 5 years prior to randomization, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, cervical carcinoma in situ, and other carcinomas in situ.

Presence of cerebrovascular or cardiovascular diseases or risk factors.

Inadequate washout from prior therapies prior to randomization.

Trial design

Treatments tested in this trial

  • JSKN016 Injection
  • Eribulin Mcsilate Injection
  • Vinorelbine Tartrate Injection
  • Capecitabine Tablets
  • Gemcitabine Hydrochloride for Injection
  • Sacituzumab Govitecan for Injection

Treatment groups

364 Participants
are divided into 2 treatment groups