Phase 3 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:

• Adult women (of any menopausal status) and adult men may be considered.
• People who have been diagnosed with a specific type of breast cancer (hormone receptor-positive, HER2-negative) confirmed by a tissue sample test.
• People whose treating doctor considers them suitable for a hormone-blocking treatment called fulvestrant, plus at least one of three specific targeted medicines (palbociclib, ribociclib, or abemaciclib), based on how well they previously tolerated these medicines.
• People whose kidneys, liver, and bone marrow are functioning well enough as shown by blood tests.
• People who agree to provide a stored tumour tissue sample for testing.

For the main part of the trial (Phase III) only, additional criteria include:

• People who have previously had hormone-based treatment for breast cancer and whose cancer came back or got worse during that treatment, or within 12 months of finishing it.
• People who agree to provide blood samples at the start of the trial for a specialised DNA test to look for certain gene changes in the cancer.
• People whose treating doctor considers them suitable for fulvestrant and at least one of two specific targeted medicines (palbociclib or ribociclib).
• People who have measurable areas of cancer that can be tracked on scans, or certain types of bone lesions visible on CT or MRI scans.

Who may not be able to join:

• People who have had another cancer in the past, unless it was treated with the intent to cure, has shown no signs of returning for at least 2 years, and carries a low risk of coming back.
• People who have had radiotherapy within 2 weeks before the start of the trial treatment.
• People who have had major surgery or a serious injury within 4 weeks before the start of the trial treatment.
• People who still have significant side effects (above a mild level) from previous cancer treatments, not including hair loss.
• People who have cancer that has spread to the spinal cord, brain, or the lining of the brain or spinal cord, unless those areas have been fully treated and have been stable without steroid medication for at least 4 weeks.
• People with certain heart-related concerns identified at screening, including an abnormal heart rhythm reading on an ECG above certain thresholds, significant heart rhythm or conduction problems, factors that raise the risk of dangerous heart rhythm changes, or certain serious heart events (such as a heart attack, heart surgery, or significant heart failure) within the past 6 months, uncontrolled blood pressure (too high or too low), or reduced heart pumping function.
• People with uncontrolled, high-grade, or symptomatic irregular heart rhythms, including atrial fibrillation.
• People with certain blood sugar problems, specifically those with type 1 or type 2 diabetes who require insulin, or those whose long-term blood sugar level (HbA1c) is at or above 8.0%.
• People who have previously had a bone marrow transplant from a donor, or a transplanted solid organ.

For the main part of the trial (Phase III) only, additional criteria include:

• People who have previously been treated with certain targeted medicines that affect specific cancer cell signalling pathways (AKT, PI3K, or mTOR inhibitors).
• People who have previously had CDK4/6 inhibitor treatment for advanced or metastatic (spread) breast cancer — though prior use of these medicines after surgery may be acceptable if at least 12 months have passed since finishing that treatment (confirm with trial site).
• People who have had more than one course of chemotherapy for metastatic breast cancer.
• People who have had any hormone-based therapy for breast cancer that has spread or cannot be removed with surgery.

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