Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis

Launched by BEIJING 302 HOSPITAL · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for women with HER2-negative breast cancer that has spread to the brain, known as brain metastasis. The researchers want to see if combining three medications—adebrelimab, apatinib, and etoposide—can effectively treat this condition. Currently, there are no standard drug treatments for this type of brain metastasis, and the study aims to explore whether this combination can improve outcomes for patients.

To participate in this trial, women must be at least 18 years old and have a confirmed diagnosis of HER2-negative breast cancer that has either newly spread to the brain or worsened after treatment. Participants should have at least one measurable brain lesion and generally be in good health, with normal organ function. They should also be able to take medications by mouth and be willing to follow the study protocol. Throughout the trial, participants can expect regular check-ups and monitoring to assess the effectiveness of the treatment and their overall health. It’s important to note that some women, such as those with certain medical conditions or recent cancer diagnoses, may not be eligible to join the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female, aged ≥18 years
• • Expected survival time ≥3 months.
• • Histologically or cytologically confirmed HER2-negative (IHC 0 or 1+; or IHC 2+ ISH negative) locally recurrent or metastatic disease
• • New brain metastasis or brain metastasis progression after treatment
• • HR+ advanced breast cancer with prior CDK4/6 inhibitor treatment failure or the investigator deems unsuitable for CDK4/6 inhibitors
• • At least one intracranial measurable lesion as defined by RECIST V1.1 criteria；
• • ECOG PS 0-2；
• • Patients must have the ability to swallow oral medication；
• • Prior WBRT, stereotactic radiosurgery, and surgical resection are allowed；
• • Organ function levels are basically normal, and the investigator believes that the study drug can be applied：
• • Voluntarily join this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up
• Exclusion Criteria:
• • Urgent need for local treatment of brain metastasis
• • Immunohistochemistry HER2 positive (IHC 3 or IHC 2 ISH amplification)
• • Previously treated with Apatinib, Avelumab, or VP-16；
• • Severe dysfunction of important organs such as the heart, liver, or kidneys；
• • Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug administration and absorption；
• • Participants diagnosed with any other malignant tumor within 5 years before this study, excluding non-melanoma skin cancer that has undergone radical treatment. Basal cell or squamous cell skin cancer or cervical carcinoma in situ and thyroid papillary carcinoma。
• • Patients who allergy to any component of the drugs in this protocol; patients with history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
• • History of any cardiac disease, including: (1) arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be unsuitable for participation in this trial, etc.
• • Pregnant or lactation female patients; females of childbearing age with a positive baseline pregnancy test or unwilling to take effective contraceptive measures during the entire trial period；
• • According to the investigator's judgment, there are severe accompanying diseases that endanger the patient's safety or affect the completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.).