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:

This trial has two groups. Please read the group that applies:

Group 1 – Advanced or metastatic breast cancer:

• People diagnosed with hormone receptor-positive (HR+), HER2-negative breast cancer that has spread or cannot be surgically removed, and who have not yet received treatment for this advanced stage
• People whose cancer tests show positive estrogen receptors and negative HER2 (confirmed by local laboratory testing)
• People whose doctors are planning to start a first treatment combining a hormone therapy (such as an aromatase inhibitor or fulvestrant) with a CDK4/6 inhibitor (a type of targeted therapy)
• People aged 18 or older at the time of signing the consent form
• People who are able to give written consent to participate
• People with a history of early breast cancer may be eligible, provided all previous systemic treatments (including hormone therapy) were stopped more than 6 months ago
• People who are willing and able to follow the study requirements for the full duration, including providing tissue and other samples
• People for whom stored tumour tissue (paraffin-embedded) from the time of their metastatic diagnosis is available (if not available, eligibility to be discussed with the trial site)

Group 2 – Early breast cancer with high risk of returning:

• People diagnosed with early-stage HR+, HER2-negative breast cancer that has spread to the lymph nodes and is considered at high risk of returning — specifically, those with 4 or more positive lymph nodes, or 1–3 positive lymph nodes plus either a high-grade tumour (grade 3) or a tumour larger than 5 cm
• People whose cancer tests show positive estrogen receptors and negative HER2 (confirmed by local laboratory testing)
• People whose doctors are planning a treatment combining a CDK4/6 inhibitor with hormone therapy (such as an aromatase inhibitor or tamoxifen, with or without an LHRH agonist) after surgery
• People aged 18 or older at the time of signing the consent form
• People who are able to give written consent to participate
• People who are willing and able to follow the study requirements for the full duration, including providing tissue and other samples
• People for whom stored tumour tissue (paraffin-embedded) from the time of diagnosis or surgery is available (if not available, eligibility to be discussed with the trial site)

Who may not be able to join:

(These exclusions apply to both groups)

• People who have already started taking a CDK4/6 inhibitor (note for Group 2: already being on hormone therapy before joining is allowed)
• People who have had a non-breast cancer diagnosis within the last 3 years (exceptions may apply for certain treated skin cancers or cervical carcinoma in situ — confirm with trial site)
• People who have taken oral or intravenous antibiotics for treating or preventing an ongoing infection within the past month (a single dose of antibiotics given before a medical procedure is allowed)
• People currently being treated with immune-system-modifying medications for an active condition (low-dose steroid creams or low-dose oral steroids equivalent to 8 mg or less of prednisone per day are allowed)
• People who test positive for HIV or hepatitis C
• People with a currently active hepatitis infection
• People with active inflammatory bowel disease or a confirmed problem absorbing nutrients from food
• People who consume more than 3 alcoholic drinks per day

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