Phase 3 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 have signed a written consent form before any trial screening begins (if someone is physically unable to sign, a witness of their choosing may confirm consent in writing on their behalf)
• People who are 18 years of age or older
• People who are female with a known menopausal status at the time of joining the trial — this includes those who have had both ovaries removed, are aged 60 or older, or meet specific hormonal or menstrual criteria confirming menopause (confirm with trial site)
• People who have been diagnosed with invasive breast cancer confirmed by tissue testing, meeting specific staging and grade criteria under standard cancer staging guidelines, where the cancer tests positive for oestrogen receptors (ER-positive, meaning at least 10% of tumour cells stain positive) and negative for HER2
• People whose doctor has decided they are suitable for chemotherapy, based on the characteristics of their cancer or results of genetic tumour testing
• People who have no medical reason preventing them from taking hormone-blocking therapy (endocrine therapy) or chemotherapy, and who are planned to receive hormone-blocking therapy for at least 5 years
• People who have had surgery to remove the breast cancer with clear margins (no cancer cells at the edges), completed within 12 weeks before joining — or, if margins were not clear, those who have planned follow-up surgery or local radiotherapy to address this
• People who are not yet in menopause and who have had a negative blood pregnancy test before starting the study treatment
• People who are not yet in menopause and who agree to use at least one effective form of contraception during treatment and for at least 21 days after the last dose of study medication (or longer if standard medical practice requires it)
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity), assessed within 28 days before joining
• People whose blood test results show adequate bone marrow, kidney, and liver function, meeting specific laboratory value thresholds (confirm with trial site for exact values)
• People whose heart electrical activity (ECG) shows a specific heart rhythm measurement (QTcF interval) below 450 milliseconds and a resting heart rate between 50 and 100 beats per minute
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures
• People who have no psychological, family-related, or geographical circumstances that would make it difficult to follow the study schedule
• People who are covered by a social security or equivalent health insurance system, as required by local rules

Who may not be able to join:

• People who have already received chemotherapy before surgery (neoadjuvant chemotherapy) for their current breast cancer diagnosis, or who have previously taken a CDK4/6 inhibitor medication
• People whose breast cancer was diagnosed while they were taking tamoxifen, raloxifene, or aromatase inhibitors for cancer risk reduction or osteoporosis treatment within the 2 years before joining
• People who have a known allergy or sensitivity to ribociclib or the hormone-blocking therapies used in the trial, including those with rare inherited conditions affecting how the body processes certain sugars, or those with soy or peanut allergies
• People with evidence or a history of breast cancer that has spread to distant parts of the body (stage IV), inflammatory breast cancer, breast cancer that has come back, or a separate previous breast cancer diagnosis
• People who have or have had another invasive cancer that was treated within the 2 years before joining (people with certain fully treated skin cancers or cervical cancer in situ may still be considered eligible)
• People whose breast cancer is considered unlikely to respond to hormone-blocking therapy, based on the treating doctor's assessment — this may include certain molecular subtypes or cancers that continued to grow rapidly during pre-surgery hormone therapy
• People who have had major surgery within 14 days before the planned start of study treatment
• People with a known HIV infection where the antiviral medications they take are known to interfere with the study drug in a way that cannot be safely managed — those with well-controlled HIV on suitable medication may still be considered if they meet specific criteria set by medical guidelines (confirm with trial site)
• People with a known active hepatitis B or hepatitis C infection
• People with significant or uncontrolled heart disease, including recent heart attack, heart muscle disease, poor heart pumping function, certain abnormal heart rhythms, or uncontrolled high blood pressure above 160 mmHg (confirm with trial site for full list)
• People with other significant medical conditions — including serious breathing problems, bowel conditions such as Crohn's disease or ulcerative colitis, ongoing severe diarrhoea, or other conditions — that the treating doctor considers would make participation unsafe or affect results
• People with a past history of lung inflammation (pneumonitis), regardless of the cause
• People who are currently taking certain medications within 7 days before joining that cannot be stopped, including strong interacting medications, grapefruit or similar fruits, or medications known to affect heart rhythm (confirm with trial site for full list)
• People currently using hormone replacement therapy, or who stopped oestrogen replacement therapy less than two weeks before starting treatment
• People who have taken steroid medications (corticosteroids) by mouth or injection within 2 weeks before starting the trial, or who have not fully recovered from their side effects (short-term, inhaled, topical, or eye-drop use may be permitted — confirm with trial site)
• People with any other serious or uncontrolled medical condition that the treating doctor believes would make participation unsafe, including serious infections, liver disease, or a life expectancy of 5 years or less
• People who have taken part in another clinical trial involving an experimental drug within 30 days before joining, or within 5 half-lives of that drug, whichever is longer
• People who are unable or unwilling to swallow tablets or capsules
• People with a condition affecting the stomach or intestines that could prevent proper absorption of the study medications
• People with psychological, family, social, or geographical circumstances that would make it difficult to follow the study schedule
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the first 48 months of treatment
• People who are under legal custody, protective supervision, or guardianship

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