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:

• People who are able to understand the study's purpose and have signed a consent form before any study procedures begin.
• Adults aged 18 or older at the time of signing the consent form.
• Pre- or peri-menopausal women, or men, where a hormone-suppressing injection (LHRH analogue) has been given for at least 28 days before starting the study treatment, or where hormone levels have been confirmed to be at post-menopausal levels through blood tests if the treatment period was shorter.
• Post-menopausal women, defined as having had no menstrual periods for at least 12 consecutive months without another medical explanation, or having had both ovaries surgically removed.
• People with breast cancer that has been confirmed by tissue testing to be hormone receptor positive (HR+) and HER2-negative, according to established medical guidelines.
• People whose cancer has spread or returned and cannot be fully removed by surgery, confirmed by CT scan or MRI.
• People who have received at least five years of hormone-blocking therapy after their initial breast cancer treatment, including at least two years of a specific type called an aromatase inhibitor (AI).
• People whose cancer has shown signs of returning or spreading either during or after their hormone-blocking therapy, whether that occurred within 12 months or more than 12 months after finishing that therapy.
• People who previously received a CDK4/6 inhibitor as part of their earlier breast cancer treatment may be eligible if their cancer progressed more than 12 months after finishing that treatment (confirm with trial site).
• People with measurable cancer that can be detected on scans, or with bone-only disease that includes at least one lytic or mixed bone lesion.
• People who have stopped taking tamoxifen or toremifene for at least 35 days before joining the trial.
• People who can provide a tissue sample taken when the cancer returned or spread, or an archived sample from the original breast cancer if a more recent one is not available.
• People whose blood counts and organ function (bone marrow, liver, and kidneys) meet specific levels set by the trial (confirm details with trial site).
• People who are willing and able to attend treatment visits and follow-up appointments as required by the study.
• Women who could become pregnant and are sexually active with a non-sterilised male partner must have a negative pregnancy blood test within 14 days before starting treatment, and must agree to use a highly effective form of contraception from screening until 4 weeks after the last dose; they must also avoid donating eggs and breastfeeding during this period. Male partners of such women must use a condom from the time their female partner joins the trial until 4 weeks after her last dose.
• Male participants who are sexually active with a female partner who could become pregnant must either be surgically sterile or use an effective form of contraception from screening until 21 days after their last dose, and must not donate or bank sperm during this period; their female partners must also use a highly effective contraception method until 4 weeks after the male participant's last dose.
• People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have minor limitations in physically strenuous activity but can carry out light work (confirm with trial site).
• People with a life expectancy of at least 6 months.

Who may not be able to join:

• People whose cancer is causing a life-threatening crisis in internal organs, or whose disease in internal organs is rapidly worsening or causing symptoms.
• People currently taking part in another treatment clinical trial.
• People who have previously been treated with a type of hormone-blocking drug called a SERD, including camizestrant or fulvestrant, or certain other experimental hormone therapies.
• People who have already received systemic (whole-body) treatment for advanced or metastatic disease.
• People with active, uncontrolled, or symptomatic cancer that has spread to the brain or the lining of the brain and spinal cord — though people with a history of brain metastases that have been treated, are currently stable, and have not needed anti-seizure medication or steroids for at least 14 days may still be considered.
• People with a history of another cancer, with some exceptions including cancers that were treated with curative intent with no known active disease for at least 3 years before the study, certain treated skin cancers with no evidence of disease, or basal cell or squamous cell skin cancers (other cases may require further discussion with the medical team).
• People with a known allergy or sensitivity to any of the study drugs or their ingredients — note that one study drug, ribociclib, is not suitable for people with a peanut or soy allergy.
• People with conditions that affect the body's ability to absorb oral medications, such as bowel obstruction, malabsorption conditions, or prior gastric bypass surgery, or people who are unable or unwilling to swallow tablets.
• People who have received targeted radiation to a small area within the last 2 weeks, or wide-field radiation covering a large area of bone marrow within the last 4 weeks before joining the trial.
• People who have had major surgery or a significant injury within 14 days before joining the trial.
• People with known blood clotting disorders, or a history of blood clotting problems such as deep vein thrombosis or pulmonary embolism within the past 6 months.
• Women who are pregnant or breastfeeding, or people unwilling to use required contraception as outlined in the protocol.
• People with a currently active and detectable HIV infection, active hepatitis B, or active hepatitis C — though people with a past resolved hepatitis B infection or a cleared hepatitis C infection confirmed by specific blood tests may still be considered.
• People with any other active, uncontrolled infection at the time of screening, known substance misuse issues, or other severe uncontrolled medical or psychiatric conditions that the trial doctor considers would make participation unsafe.

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