SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases
Eligibility criteria
Qualifiers
Age ≥ 18 years old, both genders
ECOG Performance Status of 0-2
Pathological tests confirm HR-negative/HER2-negative breast cancer；there is evidence of local recurrence or metastasis；not suitable with curative surgery or radiation therapy；HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is <10%；HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-)
Must have life-expectancy of ≥ 3 months
Disqualifiers
Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture
Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment
Has received prior therapy with bevacizumab and TROP-2 ADC drugs
Trial design
Treatments tested in this trial
- SHR-A1921 + Bevacizumab
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov