Phase 2 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 and dated the informed consent form for the trial.
• People who are over 18 years old at the time of signing the consent form.
• People who are female and whose menopausal status is known — either confirmed as postmenopausal (through surgery to remove both ovaries, being over 60, or being under 60 with no periods for at least 12 months and hormone levels in the postmenopausal range), or with menopausal status confirmed by another accepted method (confirm with trial site).
• People who have been diagnosed with invasive breast cancer in one breast, confirmed by tissue or cell testing, with the diagnosis made within the 18 months before joining the trial — including those with cancer found in more than one area of the breast, provided all areas meet the hormone receptor and HER2 criteria below.
• People whose breast cancer tests positive for estrogen receptors and/or progesterone receptors, based on the most recent tissue sample tested at a local laboratory.
• People whose breast cancer tests negative for HER2, confirmed by the most recent tissue sample tested at a local laboratory.
• People who have had surgery to fully remove the tumour with no cancer cells found at the edges of the removed tissue, and whose cancer falls into one of the following risk categories: Stage II with certain tumour and lymph node characteristics, tumour grade, or a high-risk result on a genomic (gene-based) test; or Stage III (confirm specific staging details with trial site).
• People who have already completed chemotherapy before the screening visit, if their doctor recommended it.
• People who have already completed radiotherapy before the screening visit, if their doctor recommended it.
• People who have no medical reasons preventing them from taking hormone-blocking therapy (endocrine therapy) and who plan to take it for five years or more starting from the date they are assigned to a treatment group.
• People who may have already started standard hormone-blocking therapy before joining, provided they enrol within 12 months of first starting that therapy — with specific rules applying if tamoxifen was used (confirm details with trial site).
• People who are considered generally well and able to carry out normal daily activities, as measured by a standard medical scale (ECOG score of 0 or 1).
• People whose blood counts, kidney function, and liver function meet the required levels as tested by a local laboratory.
• People whose sodium, potassium, magnesium, and calcium levels are within normal limits, or have been corrected to normal with supplements.
• People whose heart electrical activity (ECG) meets specific requirements, including a QTcF interval under 450 milliseconds and a resting heart rate between 50 and 90 beats per minute.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and procedures.
• People who could potentially become pregnant who have a negative pregnancy blood test within 14 days before enrolling, and who are willing to use highly effective contraception during the trial and for 21 days after treatment ends.

Who may not be able to join:

• People who have previously been treated with a CDK4/6 inhibitor (a type of targeted cancer drug).
• People who have used tamoxifen, raloxifene, or aromatase inhibitors to reduce the risk of breast cancer or to treat osteoporosis within the two years before signing the consent form.
• People who have previously received high cumulative doses of certain chemotherapy drugs called anthracyclines (specifically doxorubicin at or above 450 mg/m², or epirubicin at or above 900 mg/m²).
• People with a known allergy or sensitivity to ribociclib, the hormone-blocking therapy used in the trial, or certain inactive ingredients in those medicines — including those with rare inherited conditions affecting how the body processes certain sugars, or a soy allergy.
• People whose breast cancer has spread to distant parts of the body beyond the nearby lymph nodes (Stage IV), or whose cancer has returned after surgery intended to cure it.
• People currently receiving other cancer treatments, apart from hormone-blocking (endocrine) therapy.
• People who have had major surgery, chemotherapy, or radiotherapy within 14 days before enrolling.
• People who still have significant side effects (above a mild level) from previous cancer treatment at the time of enrolling — with the exception of hair loss or absence of periods, which are permitted at any level.
• People who currently have another invasive cancer, or who completed treatment for a previous invasive cancer within two years before signing the consent form — although people with a past or current non-invasive (in situ) cancer who received appropriate treatment may still be eligible (confirm with trial site).
• People with a known history of HIV infection.
• People with a known active hepatitis B or hepatitis C infection.
• People with significant or uncontrolled heart conditions, including: a history of heart attack, angina, certain heart inflammation, or bypass surgery within six months before enrolment; a diagnosed heart muscle disease; a pumping function of the heart below 50%; certain abnormal heart rhythms or electrical conduction problems; a personal or family history of long QT syndrome or unexplained sudden death; low potassium or magnesium levels that have not been corrected; a history of heart failure or significant slow heart rate; current use of medicines known to affect the heart's electrical activity that cannot be stopped or changed; or uncontrolled high blood pressure above 160 mmHg.
• People who have taken certain medications, herbal supplements, or foods within seven days before enrolment that are known to strongly affect how the body processes certain drugs — including grapefruit, pomelo, starfruit, and Seville oranges (confirm full list with trial site).
• People who have been taking systemic corticosteroids (steroid medicines taken throughout the body) within two weeks before starting trial treatment, or who have not fully recovered from their side effects.
• People who have taken certain medicines that affect the immune system or white blood cell levels within four weeks before starting trial treatment.
• People with digestive system conditions that could significantly affect how oral trial medicines are absorbed, such as uncontrolled gut disease, severe nausea, vomiting, diarrhoea, or a history of removal of part of the small bowel.
• People with other serious or uncontrolled medical conditions that, in the treating doctor's judgement, would make participation unsafe or affect the ability to follow the trial requirements — or where life expectancy is estimated at five years or less (confirm with trial site).
• People who have participated in another interventional clinical trial within 30 days before enrolling, or within five half-lives of that trial's investigational product, whichever is longer.
• People whose blood count taken within one week before starting ribociclib shows white blood cell or neutrophil counts below the normal range of the testing laboratory.
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial.

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