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:

General requirements (both parts of the trial):

• People diagnosed with breast cancer that has come back, cannot be removed by surgery, has spread to nearby areas, or has spread to other parts of the body
• People who have received at least one, but no more than two, prior chemotherapy treatments for their advanced breast cancer; people with hormone receptor-positive (ER+) breast cancer must also have had at least one prior hormone therapy for advanced disease; people with HER2-positive breast cancer must also have had at least one prior HER2-targeted treatment
• People whose cancer can be measured on scans, according to standard criteria called RECIST 1.1
• People whose blood counts and organ function test results fall within the ranges required by the study protocol, tested within one week before joining the trial
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the trial
• Women who could become pregnant, or the male partners of women who could become pregnant, must use a highly effective form of contraception for 2 weeks before starting treatment, throughout treatment, and for 1 month after stopping treatment (for women); male partners must use contraception for 14 weeks after the female patient stops treatment. Accepted methods include combined hormonal contraception (pill, patch, or vaginal ring), progesterone-only contraception (pill, injection, or implant), an intrauterine device (IUD), an intrauterine hormone-releasing system, bilateral tubal occlusion, a vasectomised partner, or complete abstinence from sex throughout the entire period of risk (confirm with trial site)
• People aged 18 or older
• People with a general health status rated as 0 or 1 on the World Health Organisation (WHO) scale, meaning they are fully active or have only minor limitations on physically demanding activity
• People whose doctor estimates their life expectancy to be at least 3 months
• People who have signed and dated a consent form agreeing to take part
• People who are willing and able to attend scheduled visits, follow appointments, have tests, and follow the study plan

Additional requirements for Part B of the trial only:

• People with a specific type of breast cancer called androgen receptor-positive (AR+) triple-negative breast cancer, where the AR status has been confirmed through central laboratory testing on stored tumour tissue
• Stored breast tumour tissue must be available (from either the original tumour or a secondary site, depending on the situation); tissue from the original tumour must have been collected within 5 years before the cancer spread (confirm with trial site)
• People with cancer that can be measured on scans and where a fresh tissue sample (biopsy) can safely be taken
• People willing to have a fresh tumour biopsy taken at the start of the trial

Who may not be able to join:

• People who have received oral chemotherapy within the past 2 weeks, weekly intravenous chemotherapy within the past 3 weeks, or any other chemotherapy or experimental treatment within the past 4 weeks
• People who have had hormone therapy within the past 7 days (note: LHRH analogues used to suppress ovarian function are permitted; bone-strengthening medications called bisphosphonates or RANK ligand inhibitors are also permitted)
• People who have previously received immune checkpoint inhibitor drugs or immune-stimulating drugs for advanced disease (note: people who received pembrolizumab before or after surgery for early breast cancer may still be eligible if that treatment finished at least 6 months before the cancer spread — confirm with trial site)
• People who have previously been treated with palbociclib or any other CDK4/6 inhibitor drug (note: people who received abemaciclib or ribociclib for early breast cancer after surgery may still be eligible if that treatment finished at least 12 months before the cancer spread — confirm with trial site)
• People who have had major surgery within the past 4 weeks, or radiotherapy within the past 14 days before joining the trial (minor procedures such as fitting a port or line are generally not considered major surgery — confirm with trial site)
• People with brain metastases that are causing symptoms and require steroid treatment, untreated brain metastases, cancer that has spread to the lining of the brain, or compression of the spinal cord
• People with an active infection that requires treatment with antibiotics or other systemic medication
• People who have had a heart attack, myocarditis, uncontrolled chest pain (angina), heart bypass surgery, heart failure with symptoms, stroke, or a mini-stroke (TIA) within the past 12 months
• People with uncontrolled high blood pressure or irregular heart rhythm, including atrial fibrillation
• People with an active autoimmune disease that could worsen with immune-stimulating treatment (note: people with type 1 diabetes, vitiligo, psoriasis, or thyroid conditions that do not require immune-suppressing treatment may still be eligible — confirm with trial site)
• People currently taking immune-suppressing medications, with some exceptions such as low-dose inhaled, nasal, topical, or injected steroids, low-dose systemic steroids (up to 10 mg per day of prednisone or equivalent), or steroids given to prevent allergic reactions to procedures (confirm with trial site)
• People with certain serious ongoing health conditions, including colitis, inflammatory bowel disease, lung inflammation (pneumonitis, even if it has fully resolved), pulmonary fibrosis, kidney failure requiring dialysis, or serious psychiatric conditions including active or recent (within the past year) thoughts of suicide or self-harm
• People taking the blood-thinning medications warfarin or direct-acting oral anticoagulants (note: people who need anticoagulation for rate-controlled atrial fibrillation or previous blood clots may be eligible if they switch to low-molecular-weight heparin — confirm with trial site)
• People with known HIV, AIDS, active Hepatitis B, or active Hepatitis C infection
• People with a history of severe allergic reactions to monoclonal antibody medications (Grade 3 or higher), any history of anaphylaxis, or uncontrolled asthma
• People who are unable or unwilling to swallow tablets or receive intravenous injections
• People who still have side effects from previous cancer treatment rated above Grade 1 in severity (except for stable nerve damage rated Grade 2 or below, or hair loss rated Grade 2 or below)
• People who are pregnant or breastfeeding
• People diagnosed with another cancer within the past 3 years (exceptions may include previous breast cancer, certain treated skin cancers, cervical carcinoma in situ, or low-grade prostate cancer — confirm with trial site)
• People currently taking part in, or planning to join, another interventional clinical trial at the same time (participation in an observational study would be acceptable)
• People with known or suspected allergy or sensitivity to the trial drugs or any of their ingredients
• People who have had a live vaccine within 4 weeks before the first dose of avelumab, or who plan to receive a live vaccine during the trial; live vaccines must also be avoided for 3 months after the last dose of avelumab (inactivated vaccines are permitted)
• People with a psychiatric condition that would prevent them from understanding or giving informed consent
• People who require continued use of St. John's Wort herbal supplement (other herbal or natural products must be discussed with the trial doctor before and during the trial)
• People who require continued use of certain medications that affect a liver enzyme called CYP3A, including inhibitors, inducers, or substrates of this enzyme (a specific list is available from the trial site)
• People with rare inherited conditions affecting the ability to process galactose or lactose, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, as the trial medication contains lactose
• People who, in the opinion of the trial doctor, are not considered suitable candidates for any other reason

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