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 signed an informed consent form before any study-related tests or procedures begin
• Adults aged 18 or older, of any gender
• People who have been confirmed through a tissue biopsy to have invasive breast cancer in one breast only, at a locally advanced stage (Stage IIA through Stage III), where the tumour tests positive for hormone receptors and negative for HER2, and where the oestrogen receptor (ER) is present in more than 20% of tumour cells
• People whose medical team (multidisciplinary tumour board) has recommended chemotherapy as part of their treatment plan
• People who have not yet received any treatment specifically for their current breast cancer when entering the screening phase
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scoring system (ECOG score of 0, 1, or 2)
• People whose blood counts and organ function (including bone marrow, kidneys, and liver) meet specific healthy ranges, confirmed by blood tests taken within 8 weeks before starting the study treatment
• People who are able to swallow and keep down oral (tablet/capsule) medication without any condition that would stop it being absorbed properly
• People who are willing and able to attend scheduled visits, follow treatment plans, and complete all required study procedures
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 28 days before registering for the trial (this test is not required for women who are post-menopausal or have had a hysterectomy)

Who may not be able to join:

• People who are not suitable candidates for local breast treatment such as surgery or radiotherapy (where recommended)
• People who have invasive breast cancer in both breasts, or who have a type of non-invasive cancer (DCIS) in the opposite breast at the same time
• People who are currently using systemic hormone therapies, such as hormone replacement therapy or hormonal contraceptives (including hormonal coils) — though topical vaginal oestrogen is permitted
• People taking any ongoing medication that is known to be unsafe to use alongside cancer treatment
• People who are currently enrolled in another interventional clinical study and receiving study treatment, or who have received study treatment within the 30 days before starting this trial
• People who have previously received systemic cancer treatment for invasive breast cancer
• People with a history of another cancer, unless they have been free of that cancer for at least 2 years and their doctor considers the risk of it returning to be very low — or unless the prior cancer was one of the following, which may still be eligible even if treated recently: non-invasive breast cancer (DCIS), cervical cancer in situ, or certain non-melanoma skin cancers
• People with medical or psychiatric conditions that, in their doctor's judgement, could affect their safety or their ability to give informed consent — for example, uncontrolled HIV infection, active hepatitis, or chronic liver disease such as cirrhosis
• People with serious ongoing or uncontrolled health conditions, including active infection, heart failure, unstable chest pain, irregular heart rhythm, uncontrolled diabetes, or mental health or social circumstances that would make it difficult to follow the study requirements
• People with significant digestive system problems that could affect how the oral study medication is absorbed — for example, severe uncontrolled nausea, vomiting, diarrhoea, conditions affecting nutrient absorption, or previous removal of part of the small bowel
• People with any other serious uncontrolled medical condition that their doctor considers would create unacceptable risks, or where life expectancy is estimated to be 5 years or less
• People who are pregnant, breastfeeding, or who plan to become pregnant or breastfeed during the study treatment period or within 6 months after it ends

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