SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases

Launched by FUDAN UNIVERSITY · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with triple-negative breast cancer (TNBC) that has spread to the brain. The study will test a combination of two medications: SHR-A1921 and Bevacizumab. The goal is to see how effective and safe this combination is for treating patients who cannot undergo surgery or radiation therapy due to their cancer's progression. This trial is currently not recruiting participants, but it is aimed at adults aged 18 and older who have certain confirmed characteristics of their breast cancer and meet specific health criteria.

To be eligible for the trial, participants must have a life expectancy of at least three months and MRI-confirmed brain metastases, meaning the cancer has spread to the brain. They should not have had recent treatments that could interfere with the study. Participants can expect close monitoring during the trial, and they will need to sign an informed consent form to agree to take part. It’s important for potential participants to understand their health status will be evaluated carefully, as the study aims to ensure their safety while exploring new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old, both genders
• • 2. ECOG Performance Status of 0-2
• • 3. 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(-)
• • 4. Must have life-expectancy of ≥ 3 months
• • 5. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy；
• • 6. Intraventricular catheter shunting or mannitol、steroid hormone、anticonvulsant drug is allowed before enrollment, but the dose of drug should be stable for at least one week and the neurological symptoms are stable for ≥1 week
• • 7. Adequate function of major organs meets the following requirements (1)Blood routine
• • ANC≥1.5×109/L；
• • PLT≥75×109/L；
• • Hb≥90 g/L(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation
• • INR≤1.5，APTT≤1.5×ULN (3)Blood biochemistry
• • TBIL≤1.5 × ULN;
• • ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN);
• • Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula) (4)Cardiac ultrasound
• * LVEF≥50%; (5)12-lead ECG:
• • females QTcF interval \<470msec and males \<450ms;
• • 8. Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.
• Exclusion Criteria:
• • 1. Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture
• • 2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
• • 3. Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment
• • 4. Has received prior therapy with bevacizumab and TROP-2 ADC drugs
• • 5. Participation in any other clinical trials within 2 weeks of enrollment
• • 6. Concurrent use of any other Anti-cancer drugs
• • 7. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma
• • 8. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study
• • 9. History of allergy or hypersensitivity to any of the study drugs or study drug components
• • 10. History of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation
• • 11. A clear history of neurological or mental disorders, including epilepsy or dementia
• • 12. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation
• • 13. According to the investigator\'s judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs)
• • 14. Any condition which in the investigator\'s opinion makes the subjects unsuitable for the study participation