JSKN003: Administered intravenously according to protocol.
Capecitabine tablets: Administered according to protocol, as one option for investigator's choice (determined before randomization).
Gemcitabine hydrochloride for injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).
Vinorelbine tartrate injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).
Paclitaxel for injection (albumin-bound type): Administered according to protocol, as one option for investigator's choice (determined before randomization).
Docetaxel injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).
Eribulin mesylate injection: Administered according to protocol, as one option for investigator's choice (determined before randomization).
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
| Facility | City | Region | Status |
|---|---|---|---|
| Erwei Song | Guangzhou | Guangdong | Not Yet Recruiting |
| Jiong Wu | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| Anyang Cancer Hospital | Anyang | China | Not Yet Recruiting |
| Affiliated Hospital of Hebei University | Baoding | China | Not Yet Recruiting |
| Beijing Luhe Hospital | Beijing | China | Not Yet Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | China | Recruiting |
| Peking University Cancer Hospital | Beijing | China | Recruiting |
| The First Affiliated Hospital of China Medical University | Beijing | China | Recruiting |
| The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army | Beijing | China | Not Yet Recruiting |
| Bethune First Hospital of Jilin University | Changchun | China | Not Yet Recruiting |
| Jilin Provincial Cancer Hospital | Changchun | China | Not Yet Recruiting |
| The First People's Hospital of Changde | Changde | China | Recruiting |
| Central South University Xiangya Hospital | Changsha | China | Not Yet Recruiting |
| Hunan Cancer Hospital | Changsha | China | Recruiting |
| Affiliated Hospital of Chengde Medical University | Chengde | China | Recruiting |
| Sichuan Cancer Hospital | Chengdu | China | Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | China | Recruiting |
| West China Hospital, Sichuan University | Chengdu | China | Not Yet Recruiting |
| Cancer Hospital of Chongqing University | Chongqing | China | Not Yet Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | China | Not Yet Recruiting |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | China | Not Yet Recruiting |
| Fujian Cancer Hospital | Fuzhou | China | Not Yet Recruiting |
| Fujian Provincial Hospital | Fuzhou | China | Recruiting |
| Union Hospital Affiliated to Fujian Medical University | Fuzhou | China | Recruiting |
| The First Affiliated Hospital of Gannan Medical University | Ganzhou | China | Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | China | Not Yet Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | China | Not Yet Recruiting |
| The Affiliated Hospital of Guangdong Medical University | Guangzhou | China | Recruiting |
| Sun Yat-sen University Cancer Center | Guanzhou | China | Not Yet Recruiting |
| Guizhou Provincial People's Hospital | Guiyang | China | Recruiting |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | China | Recruiting |
| Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine | Hangzhou | China | Not Yet Recruiting |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hanzhou | China | Not Yet Recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hanzhou | China | Not Yet Recruiting |
| Zhejiang Cancer Hospital | Hanzhou | China | Not Yet Recruiting |
| Harbin Medical University Cancer Hospital | Ha’erbin | China | Not Yet Recruiting |
| Anhui Provincial Hospital | Hefei | China | Not Yet Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | China | Not Yet Recruiting |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | China | Not Yet Recruiting |
| The First Affiliated Hospital of University of South China | Hengyang | China | Recruiting |
+ 47 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06079983 on ClinicalTrials.gov ↗ ← All trials in China