Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are female and aged 18 or older
• People whose doctors expect them to live for at least 3 months
• People with locally recurrent or metastatic breast cancer that has been confirmed through tissue or cell testing to be HER2-negative (specific test result categories apply — confirm with trial site)
• People who have new brain metastases (cancer that has spread to the brain) or whose existing brain metastases have continued to grow after treatment
• People with hormone receptor-positive (HR+) advanced breast cancer who have already received a CDK4/6 inhibitor treatment that stopped working, or whose doctor considers CDK4/6 inhibitors unsuitable for them
• People who have at least one measurable area of cancer in the brain, as defined by a standard measurement system called RECIST v1.1
• People with a functional ability score of 0–2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People who are able to swallow oral (by mouth) medications
• People who have previously had whole-brain radiation therapy, targeted brain radiation (stereotactic radiosurgery), or brain surgery are still permitted to apply
• People whose heart, liver, kidneys, and other organs are functioning at broadly normal levels, as assessed by the treating doctor
• People who are willing to participate voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments

Who may not be able to join:

• People whose brain metastases require urgent local treatment
• People whose breast cancer tests HER2-positive under specific testing criteria (IHC 3+ or IHC 2+ with ISH amplification)
• People who have previously been treated with Apatinib, Avelumab, or VP-16
• People with serious problems affecting the heart, liver, or kidneys
• People who cannot swallow, have ongoing chronic diarrhoea, or have a bowel obstruction, or other conditions that would significantly affect how the study drugs are taken or absorbed
• People who have been diagnosed with another cancer in the past 5 years, with some exceptions for certain fully treated skin cancers, cervical carcinoma in situ, and papillary thyroid carcinoma (confirm with trial site)
• People with a known allergy to any ingredient in the study drugs, a history of immune system deficiency (including HIV, active hepatitis B, hepatitis C, or other immune conditions), or a history of organ transplantation
• People with a history of significant heart conditions, including heart rhythm problems requiring medication, heart attack, heart failure, or other heart disease the doctor considers a risk
• People who are pregnant or breastfeeding, or people of childbearing potential who have a positive pregnancy test at the start of the study or who are unwilling to use effective contraception throughout the trial
• People who, in their doctor's judgement, have other serious health conditions that could put them at risk or prevent them from completing the study, such as uncontrolled high blood pressure, severe diabetes, or active infection

Important: Always verify eligibility with the trial site directly before applying.