Phase 2 Breast 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:

• The person enrolling must be female and must have signed a written consent form agreeing to participate
• The person must be 18 years of age or older at the time of signing the consent form
• A diagnosis of metastatic breast cancer (adenocarcinoma type), confirmed by tissue testing, must be in place
• The cancer must have been confirmed by tissue or cell testing to be estrogen receptor positive (ER+) and HER2 negative (HER2-)
• Surgery or radiotherapy must not be considered a curative option by the treating doctor
• The person must have previously received a CDK4/6 inhibitor (a type of targeted therapy) combined with hormone therapy for at least 12 months, with the disease staying controlled during that time, as determined by the treating doctor
• The person must have a performance status showing they are reasonably able to carry out daily activities (rated 0, 1, or 2 on a medical scale called ECOG)
• Blood, kidney, and liver function results must meet specific levels considered adequate for the study, including haemoglobin above 9.0 g/dL, platelets at or above 100 x 10⁹/L, liver enzyme levels within 2.5 times the normal upper limit, and serum albumin above 30 g/L (confirm with trial site for full blood test requirements)
• The person must be considered postmenopausal, which may include those whose periods have stopped for 12 or more months after stopping hormonal treatments (with specific hormone level requirements for those under 50), those aged 50 or over whose periods have stopped for 12 or more months, those who entered menopause due to radiation or chemotherapy, or those using a specific type of hormone-suppressing medication (GnRH analogue)
• Women who could potentially become pregnant must have a negative blood pregnancy test within 7 days before starting the trial

Who may not be able to join:

• People who currently have, or have had in the past, cancer that has spread to the brain or the membranes surrounding the brain or spinal cord
• People who are pre-menopausal or in the transition phase approaching menopause, or who are pregnant, breastfeeding, or planning to become pregnant during or shortly after the trial
• People who have significant heart or cardiovascular problems, such as moderate-to-severe heart disease, a heart attack or stroke within the past 6 months, or unstable heart rhythm or chest pain conditions
• People who have had another cancer, unless it was a fully treated early-stage cervical cancer, a treated skin cancer (basal or squamous cell), or a cancer that has been in complete remission for more than 5 years
• People who have a known allergy or medical reason preventing them from continuing treatment with a CDK4/6 inhibitor plus hormone therapy
• People who have another significant illness, neurological condition, metabolic problem, or abnormal test result that may make the study medications unsafe or affect the study results
• People who have taken part in another clinical trial involving an experimental medicine within the last 28 days before starting this trial, or within 7 times the clearance period of a previously used trial medicine (whichever is longer), or who are currently enrolled in another such trial — note that participation in observational studies or registries without an experimental treatment is permitted
• People who have another existing medical condition that the investigator judges would significantly increase the risks of participating in the trial
• People who are currently in prison or have been placed in an institution by a court or legal authority
• People who are unable to give informed consent because they cannot fully understand the nature and implications of the trial

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