JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
Study summary
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
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — up to approximately 3 years after the first enrollment
PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.
Trial sites (87)
| 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.
More Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials in China
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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