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 have been confirmed by tissue or cell testing to have invasive breast cancer.
• All types of breast cancer (by tissue appearance) are included.
• People who have been clinically diagnosed with stage III inflammatory breast cancer within the past 6 months.
• People whose tumour has been tested and found to be HER2-positive or HER2-low, according to current testing guidelines (confirm with trial site for exact testing details).
• Any level of hormone receptor expression (ER and PR) is permitted, but these levels must already be known.
• People who have not yet received any treatment for their current breast cancer diagnosis.
• People who agree to have two research biopsies taken from the tumour (if the treating doctor determines this can be done safely) — one before treatment starts and one after the first week of treatment — as well as providing any previously collected tumour tissue.
• Women (pre- or post-menopausal) or men aged 18 years or older.
• People who are generally well enough to carry out light activity and care for themselves, based on a standard health performance scale (confirm with trial site).
• People whose heart pumping function is at least 50%, measured within 28 days before joining.
• People whose blood counts, liver, kidney, and other organ functions meet specific healthy ranges as measured by blood tests before joining (confirm with trial site for exact values).
• Women who could become pregnant, and female partners of male participants who could become pregnant, must agree to use at least one highly effective non-hormonal form of contraception (or two effective non-hormonal methods) during treatment and for 7 months after the last dose of the study drug durvalumab.
• Male participants who are sexually active with women who could become pregnant must agree to use contraception during treatment and for 4 months after the last dose of durvalumab.
• People with a life expectancy of at least 12 weeks.
• People who weigh more than 30 kg.
• People who are able to understand and follow the study requirements and are willing to sign a written consent form.

Who may not be able to join:

• People who have already received any systemic treatment for their current inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy.
• People who have already had radiotherapy or surgery for their current inflammatory breast cancer (tumour biopsies do not count as surgery for this purpose).
• People who have had a severe allergic reaction to durvalumab, trastuzumab deruxtecan, or other similar antibody-based medicines in the past.
• People who have had major surgery within 4 weeks before the study treatment starts, or who have not yet fully recovered from surgery.
• People with serious uncontrolled illnesses such as active infections, uncontrolled high blood pressure, unstable heart conditions, uncontrolled irregular heartbeat, serious ongoing gut problems with diarrhoea, or mental health or personal circumstances that would make it difficult to follow the study requirements.
• People who have needed regular daily steroid medication (above a low threshold) or other immune-suppressing medicines in the past 2 years (hormone replacement therapies for conditions like thyroid or adrenal insufficiency are not counted as immune-suppressing for this purpose).
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, Graves' disease, and similar conditions. Some exceptions may apply — for example, people with stable thyroid conditions on replacement therapy, vitiligo, hair loss, certain controlled skin conditions, or coeliac disease managed by diet, may still be considered after discussion with the principal investigator (confirm with trial site).
• People with a history of lung inflammation (ILD/pneumonitis) that required steroid treatment, or who currently have lung inflammation, or where lung inflammation cannot be ruled out on imaging at screening.
• People with significant ongoing lung conditions such as recent blood clots in the lungs (within 3 months), severe asthma, severe COPD, restricted lung function, fluid around the lungs, or autoimmune or inflammatory conditions affecting the lungs, or people who have had a lung removed.
• People whose heart's electrical activity (QT interval) is prolonged beyond a certain level on an ECG at screening.
• People with factors that increase the risk of dangerous heart rhythm problems, such as heart failure, low potassium, inherited long QT syndrome, or a family history of unexplained sudden death under age 40.
• People who have had certain heart or blood vessel procedures or events in the 6 months before joining, including heart bypass surgery, angioplasty, stent placement, heart attack, angina, moderate-to-severe heart failure, or stroke.
• People whose heart pumping function falls outside the normal range or is below 50% on heart imaging.
• People with a history of another cancer, unless that cancer was treated with the intention to cure, has shown no signs of return for at least 5 years, and carries a low risk of coming back. Some skin cancers or pre-invasive cancers that have been fully treated with no remaining signs of disease may be exceptions (confirm with trial site).
• People who have had a blood clot in a vein in the past 3 months.
• People with a history of a primary immune deficiency condition.
• People with active tuberculosis, active hepatitis B, or active hepatitis C infection. People with a past (resolved) hepatitis B infection, or people who test negative for active hepatitis C by a specific RNA test, may still be considered (confirm with trial site).
• People who are known to have previously tested positive for HIV.
• People who have received a live vaccine (such as for measles, mumps, rubella, chickenpox, or yellow fever) within 30 days before starting the study treatment. Inactivated flu vaccines are allowed.
• People with any other condition, treatment history, or test result that, in the treating doctor's judgement, could interfere with the study or would not be in the person's best interest.
• People who have taken certain medications that strongly affect how the liver processes drugs (specific CYP3A4 or related enzyme inhibitors, inducers, or substrates) within 2 weeks before starting treatment (or 3 weeks for St John's Wort).
• People who have taken hydroxychloroquine within 14 days before the first dose of trastuzumab deruxtecan.
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord.
• People who are pregnant, breastfeeding, or capable of becoming pregnant and not willing to use effective contraception from the start of the study until at least 6 months after the last dose of durvalumab and at least 7 months after the last dose of trastuzumab deruxtecan.

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