JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
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: *…
Conditions studied
Breast Cancer
About this study
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
Interventions
- Drug: JSKN003 — Administered intravenously according to protocol.
- Drug: Capecitabine tablets — Administered according to protocol, as one option for investigator's choice (determined before randomization).
- Drug: Gemcitabine hydrochloride for injection — Administered according to protocol, as one option for investigator's choice (determined before randomization).
- Drug: Vinorelbine tartrate injection — Administered according to protocol, as one option for investigator's choice (determined before randomization).
- Drug: Paclitaxel for injection (albumin-bound type) — Administered according to protocol, as one option for investigator's choice (determined before randomization).
- Drug: Docetaxel injection — Administered according to protocol, as one option for investigator's choice (determined before randomization).
- Drug: Eribulin mesylate injection — Administered according to protocol, as one option for investigator's choice (determined before randomization).
Primary outcomes
- Progression Free Survival (PFS) (up to approximately 3 years after the first enrollment)
Eligibility information
Study locations
- Erwei Song, Guangzhou, Guangdong China
- Jiong Wu, Shanghai, Shanghai Municipality China
- Anyang Cancer Hospital, Anyang, China
- Affiliated Hospital of Hebei University, Baoding, China
- Beijing Luhe Hospital, Beijing, China
- Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
- Peking University Cancer Hospital, Beijing, China
- The First Affiliated Hospital of China Medical University, Beijing, China
- The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army, Beijing, China
- Bethune First Hospital of Jilin University, Changchun, China
Showing 10 of 87 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.