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:

• Women aged 18 to 75 years who are either postmenopausal or still having periods (premenopausal or perimenopausal), meeting specific hormonal conditions — such as having had both ovaries removed, being aged 60 or over, being naturally postmenopausal for at least 12 months, or being willing to receive a hormone-suppressing injection (LHRH agonist) during the study
• People with breast cancer that has been confirmed by tissue testing to be hormone receptor (HR) positive and HER2 negative, where the cancer has come back or spread and cannot be cured by surgery or radiation, and where chemotherapy is not currently considered necessary
• People whose cancer cells show at least 1% positive staining for oestrogen receptors (ER) and/or progesterone receptors (PR), as confirmed by the trial centre
• People whose cancer tests HER2-negative based on standard laboratory methods, as confirmed by the trial centre
• People with a general health and activity level rated 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light work)
• People who have not yet received any systemic cancer treatment for the recurrent or metastatic disease
• People who have measurable tumour lesions according to standard imaging criteria, or who have bone metastases only (including bone lesions that are breaking down or a mix of breaking down and hardening)
• People whose organs (such as kidneys and liver) and bone marrow are functioning well enough to safely participate
• Women who could become pregnant and are willing to use a highly effective, medically approved form of contraception throughout the study and for 3 months after the last dose of the study drug
• People whose side effects from any previous cancer treatment have mostly or fully resolved before joining the trial (with some exceptions, such as hair loss, at the investigator's discretion)
• People who have given written informed consent and are willing and able to attend visits and follow the trial procedures

Who may not be able to join:

• People previously diagnosed with HER2-positive breast cancer by tissue testing
• People with inflammatory breast cancer
• People whose cancer got worse or came back within 12 months of finishing a previous hormone-based treatment given before or after surgery
• People the investigator considers unsuitable for hormone-based treatment — including those with rapidly progressing disease affecting internal organs, uncontrollable fluid build-up in the chest, heart, or abdomen, cancer spread through the lung's lymph vessels, or more than 50% of the liver affected by cancer
• People confirmed to have cancer spread to the brain (confirmed by CT or MRI scan)
• People who have previously been treated with a CDK4/6 inhibitor drug (a type of targeted cancer therapy)
• People who have had major surgery, chemotherapy, radiation, or any other investigational or anticancer treatment within 2 weeks before joining the study
• People diagnosed with another cancer within the past 3 years, except for certain treated skin cancers or cervical carcinoma in situ that have been fully treated
• People with HIV infection or AIDS, active hepatitis B, active hepatitis C, or a combination of hepatitis B and C infections
• People who experienced a serious heart or blood vessel event in the 6 months before joining — such as a heart attack, severe chest pain, significant heart failure, certain heart rhythm problems, atrial fibrillation, heart bypass surgery, stroke, or blood clots in the lungs
• People who had a severe infection requiring intravenous antibiotics, antifungals, or antivirals within 4 weeks before the first dose, or who have an unexplained fever above 38.5°C during screening
• People who are unable to swallow tablets, have a bowel obstruction, or have other conditions that would affect how the study drug is taken or absorbed
• People with a known allergy to the study drug or any of its ingredients
• People with a history of receiving a transplanted organ or bone marrow/stem cells from another person
• People with a known history of psychiatric drug abuse or drug addiction
• People currently taking part in another clinical study
• People with other serious physical or mental health conditions, or significant abnormal lab results, that the investigator believes would make participation unsafe or affect the study results

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