HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
To explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (HIM).
Eligibility criteria
Qualifiers
More than 18 years old;
ECOG PS Score: 0~1;
Patients must have a life expectancy ≥ 3 months;
Histopathologically confirmed recurrent metastatic triple-negative invasive breast cancer (HER2-negative: IHC 0/1+ or IHC 2+ with negative ISH; ER-negative: IHC <1%, PR-negative: IHC <1%)；
Disqualifiers
Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture;
Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g.；
Received systemic anti-tumor therapy within 14 days prior to enrollment;
Imaging shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade critical vessels during the study period, leading to life-threatening hemorrhage；
Trial design
Treatments tested in this trial
- Camrelizumab
- Nab-paclitaxel
- SKB264
- Lenvatinib
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov