Phase 1 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 are in good general health and able to carry out daily activities with little or no limitation (as measured by a standard medical scale called ECOG, with a score of 0 or 1).
• People who have one or more specific gene changes (mutations) in a gene called PIK3CA, found in a blood or tumour sample.
• People who are able to provide a stored tumour tissue sample, or who are willing to have a tumour biopsy taken before treatment starts, so the PIK3CA gene change can be confirmed.
• For the single-agent part of the trial: people whose cancer cannot be surgically removed or has spread to other parts of the body, and whose disease has not responded to standard treatments, cannot tolerate standard treatments, or who have chosen not to have standard treatments.
• For the single-agent expansion part: people with one of the following cancer types — clear cell ovarian cancer, head and neck squamous cell carcinoma, cervical cancer, certain other solid tumours (excluding colorectal, clear cell ovarian, head and neck squamous cell, and cervical cancers), or tumours with two PIK3CA mutations.
• For the combination treatment parts: people with a confirmed diagnosis of hormone receptor-positive (HR+), HER2-negative breast cancer that has spread or cannot be surgically removed and cannot be cured.
• For the combination treatment parts: people who have previously been treated for breast cancer with specific types of therapies, which may include a limited course of chemotherapy, at least one CDK4/6 inhibitor, at least one anti-oestrogen therapy, and (where relevant) a PARP inhibitor if a BRCA gene mutation is present (confirm specific prior treatment requirements with trial site, as they vary by treatment group).
• For one specific doublet combination group: people who previously received a PI3Kα, AKT, or mTOR inhibitor and stopped due to side effects (not because the cancer got worse), not including severe allergic or life-threatening reactions.
• For one specific triplet combination group: people whose disease progressed during or within 12 months of completing hormone therapy, and who are intolerant of or have declined standard treatment for advanced HR+/HER2- PIK3CA-mutated breast cancer (confirm specific prior treatment requirements with trial site).

Who may not be able to join:

• People who have previously been treated with PI3Kα, AKT, or mTOR inhibitors (this exclusion does not apply to all parts of the trial — confirm with trial site which arms this applies to).
• People who have previously been treated with immune checkpoint inhibitor medicines.
• For one specific triplet combination group: people who have previously received chemotherapy or antibody-drug treatments for advanced or spread disease, or prior CDK2, CDK4, or CDK4/6 inhibitors for advanced or spread disease, or fulvestrant (or similar medicines) except when used for a short period as pre-surgery treatment only.
• People with Type 1 or Type 2 diabetes who require blood sugar–lowering medication, or people whose fasting blood sugar and a related blood marker (HbA1c) are both above certain levels.
• People with a known allergy or sensitivity to the ingredients in PI3K inhibitor medicines, or (for combination arms) to fulvestrant, palbociclib, ribociclib, or PF-07220060 as relevant.
• People with a history of, or current, lung inflammation (interstitial lung disease or pneumonitis) that required medical treatment (people with a past mild case that fully resolved may be considered in some parts of the trial — confirm with trial site).
• People whose heart's electrical activity shows a prolonged QT interval above certain thresholds on a heart tracing (ECG) — specific cut-off values vary depending on the treatment combination involved (confirm with trial site).
• People who have cancer that has spread to the brain or spinal cord and is causing worsening neurological symptoms.

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