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 given written consent to take part in all study procedures, as required by local rules.
• People with a new, untreated breast cancer in one breast only, confirmed by a core needle biopsy (fine-needle aspiration alone or surgical biopsy are not accepted).
• People whose breast tumour can be measured in two directions, preferably by ultrasound.
• People whose cancer is at a stage described as cT1b to cT3, regardless of whether lymph nodes are involved. If there are multiple tumours, the largest one is used for measurement.
• People whose breast cancer tests positive for both hormone receptors (HR+) and HER2 (HER2+), confirmed by a central laboratory, including specific tests for ER, PR, HER2, a gene mutation called PIK3CA, Ki-67 levels, and TILs — all from the core biopsy sample.
• People aged 18 or older, of any gender.
• People who are generally well enough to carry out daily activities, as measured by a standard health performance score of 0 or 1.
• People with normal heart function, confirmed by ECG and heart scan within the 3 months before joining, with a heart pumping function (LVEF) above 55%.
• People whose recent blood test results meet the required levels for blood cell counts, liver function, and blood sugar control (HbA1c below 6.5%).
• Women who could become pregnant must have a negative pregnancy test within 14 days before joining.
• Women who could become pregnant must agree to use highly effective non-hormonal contraception, or remain abstinent, during treatment and for at least 7 months after the last dose. Men must use a condom with spermicide during treatment and for 7 months after the last dose, and both men and women must not donate eggs or sperm during this time.
• People who have had the required breast imaging (mammography, MRI, and/or ultrasound) as part of their staging assessment before joining.
• People who are willing and able to attend visits and follow the study schedule.

Who may not be able to join:

• People whose breast cancer is HER2-negative, or HER2-positive but hormone receptor-negative.
• People who need to start chemotherapy immediately, for example those with inflammatory breast cancer.
• People whose cancer has spread to other parts of the body (Stage IV).
• People who have already had surgery to remove the tumour, lymph node removal, or sentinel lymph node biopsy before joining (biopsy of a clinically affected lymph node is acceptable).
• People who have already received chemotherapy, hormone therapy, or radiation therapy, with the exception that hormone therapy started up to 28 days before joining, or established fertility preservation treatments, may be allowed.
• People with a history of breast cancer, unless they have been free of disease for more than 5 years and the treating doctor considers the risk of it returning to be low.
• People with a history of any other cancer where the risk of it returning is considered high, or where cancer treatment is ongoing or likely to be needed during the study.
• People with a known allergic reaction to any of the medicines or substances used in this trial, including murine proteins or recombinant human hyaluronidase.
• People with a confirmed diagnosis of Type 1 diabetes, or Type 2 diabetes that is not well controlled.
• People with a weakened immune system due to HIV or use of immune-suppressing medicines.
• People with significant active liver disease, such as active hepatitis B or C infection or autoimmune liver conditions.
• People with inflammatory bowel conditions such as Crohn's disease or ulcerative colitis, or active bowel inflammation.
• People with any active or serious eye condition (other than cataracts) that would need treatment during the study, or a history of or active uveitis, vitritis, or eye infection.
• People with current pneumonitis or interstitial lung disease.
• People with significant heart conditions, including heart failure above the mildest level, coronary artery disease, angina requiring medication, previous heart attack, uncontrolled high blood pressure (above 160/90 mmHg despite three blood pressure medications), serious heart rhythm problems, or significant heart valve disease.
• People with damaged skin at the thigh, where the injection would be given.
• People who have recently had a blood clot and whose blood-thinning medication has not yet been stabilised.
• People currently taking chronic corticosteroids (unless started more than 6 months ago at a low dose), sex hormone therapies, other experimental drugs, or any other cancer treatment.
• People who have taken part in another clinical trial involving an experimental drug within the 30 days before joining.
• Women who are pregnant or breastfeeding at the time of joining.
• People with a significant history of neurological or psychiatric conditions, including psychosis, dementia, or seizures, that would prevent them from understanding and consenting to the study.
• People with any other condition that, in the treating doctor's opinion, would affect the study or their safety. (confirm with trial site)
• People with a BMI over 30 may still be considered at the treating doctor's discretion (confirm with trial site).

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