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 or older who have invasive breast cancer that has spread to other parts of the body (metastatic), confirmed by tissue or cell testing, or clearly shown on physical examination or imaging scans
• People whose most recent biopsy results show low levels of hormone receptors (HR) and no overexpression of the HER2 protein, based on specific laboratory test results (confirm with trial site for exact definitions)
• People who have at least one tumour that can be measured on scans
• People who have not previously received chemotherapy specifically for their metastatic disease; prior hormone (endocrine) therapy for metastatic disease is allowed
• People who have not previously been treated with a CDK4/6 inhibitor, or who received one as an earlier preventive treatment but stopped it more than one year before their cancer returned or spread
• People who are reasonably well and able to carry out daily activities, with a life expectancy of more than 12 weeks (based on a standard medical fitness scale)
• People whose major organs (such as liver, kidneys, and bone marrow) are functioning adequately
• People who have recovered from any side effects of previous treatments to a mild or absent level before joining the trial
• People without major organ failure or significant heart disease
• People of childbearing potential who agree to use appropriate contraception before and throughout the trial

Who may not be able to join:

• People with active, uncontrolled cancer spread to the brain or the lining around the brain, unless the brain metastases have been treated and shown to be stable on imaging for at least one month, without the need for significant steroid medication or ongoing symptoms
• People who have received radiotherapy, chemotherapy, major surgery, targeted therapy, or immunotherapy within 2 weeks before joining, or hormone therapy within 1 week before joining; or certain specific chemotherapy drugs (nitrosourea or mitomycin) within 6 weeks before joining
• People who have taken part in another clinical trial of a new drug within 4 weeks before joining
• People with fluid build-up in body cavities (such as the chest or abdomen) that cannot be controlled by draining or other methods
• People who have had another cancer in the past 3 years, except for certain early-stage or skin cancers that have been fully treated (such as cervical carcinoma in situ, basal cell skin cancer, or squamous cell skin cancer)
• People with serious or uncontrolled medical conditions, including active viral infections (such as HIV or active hepatitis B or C), serious heart problems (such as uncontrolled high blood pressure, recent heart attack, severe heart failure, or significantly reduced heart pumping function), or a severe infection requiring intravenous medications within 4 weeks before starting, or an unexplained high fever during screening
• People with a history of substance misuse involving psychoactive drugs who are unable to stop, or people with mental health conditions that would affect participation; or people who have difficulty swallowing or absorbing medication
• People with other ongoing illnesses that, in the treating doctor's judgement, could seriously affect their safety or their ability to complete the trial
• People with a known allergy to the components of the trial treatment, a history of immune system deficiency (including HIV or hepatitis C), or a history of organ transplantation
• Women who are pregnant or breastfeeding
• People considered unsuitable for the trial by the treating doctor, for any reason

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