Phase 2 Breast Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 to 70 years old, of any gender
• People whose general health and ability to carry out daily activities falls within a certain range (confirm with trial site regarding the ECOG 0–2 scale)
• People who have been diagnosed through lab testing with a type of breast cancer that is both hormone receptor-negative (ER and PR negative, with less than 1% of tumour cells staining positive) and HER2-negative (confirmed by specific lab tests)
• People whose cancer has come back locally or spread to other parts of the body, and for whom curative surgery or radiation therapy is not appropriate
• People who have either never received platinum-based chemotherapy drugs before, or who received only one course of cisplatin or carboplatin and whose cancer did not worsen during at least 4 cycles of that treatment, with more than 3 months passing between the last platinum treatment and any disease progression
• People who have brain metastases confirmed by MRI, with at least one brain lesion measuring 1.0 cm or more at its longest point, that has not previously been treated with radiotherapy
• People who may be taking mannitol or steroid medication before joining, provided the steroid dose has been stable for at least one week
• People whose blood, heart, liver, and kidney function results meet the required levels (confirm specific values with trial site)
• People who are willing to sign a consent form, follow the study requirements, and attend follow-up appointments

Who may not be able to join:

• People whose cancer has spread to the lining around the brain or spinal cord, or who have cystic brain metastases, confirmed by MRI or spinal fluid testing
• People who have uncontrolled fluid build-up in body cavities (such as large amounts of fluid around the lungs or in the abdomen) that cannot be managed by drainage or other means
• People who have had whole-brain radiotherapy, chemotherapy, or brain surgery within the 14 days before joining, or who have received targeted therapy or hormone therapy within the week before joining
• People with HR-negative/HER2-negative breast cancer who have previously been treated with bevacizumab or certain immunotherapy drugs (PD-1 or PD-L1 inhibitors)
• People who have taken part in another clinical trial within 2 weeks of joining this one
• People who are currently taking other anti-cancer medications at the same time
• People who have had another cancer within the past 5 years, except for certain cancers considered fully cured (such as cervical cancer in situ, basal cell skin cancer, or squamous cell skin cancer)
• People with a history of certain heart conditions, including arrhythmias requiring treatment, heart attack, heart failure, or other heart disease considered unsuitable by the study doctor
• People with a known allergy or sensitivity to any of the medications used in this study
• People with a history of immune system disorders, including HIV, active hepatitis B or C, other immune deficiency conditions, or a history of organ transplantation
• People with a confirmed history of neurological or mental health disorders, including epilepsy or dementia
• People who are pregnant or breastfeeding, or people of childbearing potential who test positive for pregnancy or who are unwilling to use adequate contraception during the study
• People who have other serious medical conditions that the study doctor believes could put them at risk or affect their ability to complete the study (such as uncontrolled high blood pressure, severe diabetes, active infection, or uncontrolled thyroid disease)
• People who the study doctor considers unsuitable for any other reason

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