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:

• People who have been confirmed by tissue testing to have invasive breast cancer that is estrogen receptor (ER) positive (more than 1% positive).
• People whose cancer has spread locally or to other parts of the body, with at least one area of cancer that can be measured on scans.
• People who have not yet received chemotherapy for their locally advanced or metastatic breast cancer.
• People whose cancer either came back within 2 years of finishing hormonal therapy, or who have tried up to 2 hormonal therapy treatments for advanced or metastatic disease that stopped working.
• Women who are premenopausal or perimenopausal (still having periods or in the transition to menopause), confirmed by medical history or hormone blood tests. Women whose menopausal status cannot be confirmed because they are on LHRH agonist treatment may still be eligible if there is evidence they were premenopausal before starting that treatment (confirm with trial site).
• People with a good general level of physical functioning, able to carry out normal daily activities with little or no limitation (ECOG score of 0 or 1).
• People whose blood tests show that their bone marrow, liver, and kidneys are working well enough, tested within 14 days before joining the trial (confirm with trial site for specific values).
• People aged 21 years or older.
• Women of childbearing potential who have a negative pregnancy test within 7 days before starting treatment, and who are not breastfeeding.
• People of reproductive potential who are willing and able to use effective contraception (hormonal or barrier methods) before, during, and for 6 months after the trial.
• People (or their nominated representative) who are able to follow study procedures and provide signed, written informed consent.
• People who weigh more than 30 kg.
• People with a life expectancy of at least 12 weeks.

Who may not be able to join:

• People who have previously been treated with capivasertib, fulvestrant, or anti-PD1 or anti-PD-L1 immunotherapy.
• People who have previously received chemotherapy for locally advanced or metastatic breast cancer.
• People who received wide-field radiotherapy within 4 weeks before the first dose of study treatment.
• People whose breast cancer tests positive for the HER-2 protein at a level classified as IHC 3+, or IHC 2+ confirmed by another test (ISH positive).
• People with active or unstable cancer spread to the brain or spinal cord. People with treated, stable brain metastases that cause no symptoms and have not required steroid treatment for at least 4 weeks may still be considered (confirm with trial site).
• People who have had another cancer within the past 5 years, except for fully treated and cured basal cell or squamous cell skin cancer, or very early-stage cervical cancer (carcinoma in situ).
• People with a mental health condition or social situation that would make it difficult to follow the study requirements.
• People with serious wounds, ulcers, or bone fractures that are not healing.
• People who have had a major surgical procedure, open biopsy, or significant injury within 28 days before joining.
• People who have had minor surgery within 7 days before joining.
• People with a history of allergic reactions to medications chemically similar to the study drugs.
• People who are pregnant or breastfeeding.
• People who still have side effects from previous cancer treatment (other than hair loss) that are rated as more than mild (above Grade 1) at the time of starting the study.
• People with active tuberculosis, active hepatitis B, or active hepatitis C infection. People with a past hepatitis B infection that has resolved, or hepatitis C antibodies but no detectable hepatitis C virus in the blood, may still be considered (confirm with trial site).
• People who have tested positive for HIV.
• People who have received an organ transplant from another person.
• People with active or previously documented autoimmune or inflammatory conditions (such as Crohn's disease, colitis, lupus, rheumatoid arthritis, and similar conditions). Some exceptions may apply, such as people with vitiligo, stable thyroid conditions on hormone replacement, or certain skin conditions not requiring systemic treatment (confirm with trial site).
• People with uncontrolled serious ongoing illnesses, including uncontrolled infection, heart failure, uncontrolled high blood pressure, unstable heart conditions, lung disease, severe digestive problems, or conditions that would prevent them from swallowing or absorbing the study medication properly.
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis).
• People who have previously had a bone marrow transplant from another person, or a solid organ transplant.
• People who have used immune-suppressing medications within 14 days before the first dose of treatment. Some exceptions apply, including low-dose or topical steroids (confirm with trial site).
• People who have received a live vaccine within 30 days before starting treatment.
• People with certain heart problems identified at screening, including abnormal heart rhythm readings, a weakened heart pumping function, a history of heart attack, bypass surgery, or heart failure within the past 6 months, uncontrolled low blood pressure, or certain inherited heart conditions (confirm with trial site for specific measurements).
• People with poorly controlled diabetes, including those requiring insulin treatment, or those with a blood sugar control measure (HbA1c) of 8.0% or higher.
• People who have taken another experimental drug within 30 days before the first dose of study treatment.
• People currently taking certain medications that strongly affect how the body processes the study drugs (specific enzyme inhibitors, inducers, or sensitive substrates — confirm with trial site).
• People currently participating in another clinical trial involving an experimental medicine.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients, including capivasertib, fulvestrant, durvalumab, or goserelin.
• People whom the trial investigator believes should not participate for reasons related to their ability to safely follow the study requirements.

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