Combination treatment for HER2-negative breast cancer brain metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a combination therapy using Adebrelimab, Apatinib, and Etoposide for patients with HER2-negative breast cancer that has metastasized to the brain. The study aims to evaluate the central nervous system objective response rate by targeting tumor growth through immunotherapy and chemotherapy. Participants will be closely monitored for their response to the treatment and overall survival. The trial is designed for patients who have experienced progression of their brain metastasis after previous treatments.

Why it matters

Who can join: the full rules

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.).

Where it's running

• The Fifth Medical Center of PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jinmei Zhou, Doctor
• Email: jinzhu2714@sina.com
• Phone: +86-010-66947250

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

  This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Alternating liver-artery and IV chemotherapy with optional adebrelimab and apatinib for unresectable biliary tract cancer

  This study will test whether alternating hepatic arterial infusion chemotherapy and standard IV gemcitabine–cisplatin, with or without the immunotherapy adebrelimab and the targeted drug apatinib, helps people with unresectable biliary tract cancer shrink tumors and live longer.

  Recruiting Phase 2 Air Force Military Medical University, China · Xi'an, Shaanxi · NCT07569679

• Adebrelimab and apatinib with SOX chemotherapy to make advanced stomach or GE junction cancer operable

  This treatment tests whether adding adebrelimab and apatinib to SOX chemotherapy can shrink advanced stomach or gastroesophageal junction adenocarcinomas so more people can have surgery.

  Recruiting Phase 2 Beijing Friendship Hospital · Beijing, Beijing Municipality · NCT07353684

• Combining Apatinib, Adebrelimab, and Chemotherapy for Advanced Intrahepatic Cholangiocarcinoma

  This study is testing a new treatment that combines two medications with chemotherapy to see if it can help people with advanced liver cancer respond better than with standard chemotherapy alone.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT06925516

• Combining Adebrelimab, Apatinib Mesylate, and Chemotherapy for Treating Limited-stage Small Cell Lung Cancer

  This study is testing a new combination of a drug called adebrelimab, another drug called apatinib mesylate, and chemotherapy to see if it helps people with newly diagnosed limited-stage small cell lung cancer.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06483282

• Using Adebrelimab and Apatinib for treating advanced small cell lung cancer

  This study is testing if a combination of Adebrelimab and Apatinib can help people with advanced small cell lung cancer live longer and feel better after their initial treatment.

  Recruiting China Medical University, China · Shenyang, Liaoning and 1 other locations · NCT06480864

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.