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 given written consent to take part and are willing to attend all required visits and follow-up appointments.
• Postmenopausal women aged 18 or older at the time of diagnosis. Postmenopausal status is defined as being aged 60 or over; or under 60 with no menstrual periods for at least 12 consecutive months for no reason other than menopause; or having had both ovaries surgically removed. Women aged 50 or under who have not had both ovaries removed must also have a negative pregnancy test within 14 days before being assigned to a treatment group.
• People diagnosed with a specific type of breast cancer called invasive lobular carcinoma, affecting one or both breasts, that has not yet been treated. If both breasts are affected, both must be lobular type. This diagnosis must be confirmed by a central laboratory.
• People able to provide a stored tissue sample (taken by needle biopsy before treatment begins) for testing.
• People whose cancer has been centrally confirmed to be HER2-negative and hormone receptor (HR)-positive, with a specific cell activity marker (Ki67) above 10%, tested on the original biopsy sample.
• People whose cancer is considered high risk, meaning the tumour is of a certain size or has spread to nearby lymph nodes (confirm exact staging criteria with trial site).
• People with no signs that the cancer has spread to distant parts of the body.
• People with a good general level of physical functioning, as measured by a standard medical scale (ECOG score of 0 or 1), meaning they are fully active or have only minor limitations in physical activity.
• People with an estimated life expectancy of at least 5 years, not counting the breast cancer diagnosis.
• People with normal heart function as confirmed by local medical guidelines.
• People whose blood test results meet specific minimum levels for blood cell counts, liver function, blood sugar control, and kidney function (confirm exact values with trial site).
• People who have had a full set of tests to check for cancer spread, completed before starting treatment, as per standard medical practice.

Who may not be able to join:

• Women who are still able to become pregnant.
• People who have already had surgery to remove breast tissue (such as a lumpectomy or excisional biopsy) before entering the study.
• People who have already had a surgical procedure to check the lymph nodes under the arm, such as a sentinel lymph node biopsy (note: a fine needle or core needle biopsy of a lymph node is generally acceptable — confirm with trial site).
• People who have already received any treatment for their current breast cancer, including hormone therapy, chemotherapy, radiotherapy, or targeted drug treatments.
• People currently using herbal or natural products intended to treat or prevent any type of cancer.
• People with a known allergic reaction to any of the substances used in this trial.
• People taking certain strong medications that affect how the body processes a specific group of drugs (known as potent CYP3A4 inhibitors or inducers) within 2 weeks before the first dose of study treatment (or 3 weeks for St John's Wort).
• People with ongoing nausea or vomiting that cannot be controlled, chronic gut or digestive conditions, difficulty swallowing, or a history of major bowel surgery that could affect how the study drug is absorbed by the body.
• People for whom one of the study drugs (fulvestrant) is medically unsuitable.
• People with confirmed evidence that their cancer has spread to other parts of the body (stage IV or metastatic disease).
• People with a history of another cancer, unless they have been cancer-free for at least 5 years and are considered low risk for that cancer returning — or unless the prior cancer was a non-invasive cervical condition, or a basal or squamous cell skin cancer.
• People with a history of type 1 or type 2 diabetes who require insulin.
• People with serious health conditions that could interfere with taking part or receiving the study drugs, including recent stroke or mini-stroke, recent blood clot in the lungs, or an active infection requiring intravenous (drip) antibiotics or antiviral/antifungal treatment within the week before joining (people with a confirmed condition called Gilbert's syndrome may still be eligible — confirm with trial site).
• People with a known medical history of HIV, tuberculosis, or hepatitis B.
• People with a history of significant heart problems, including heart failure, certain irregular heart rhythms, a heart attack within the last 6 months, chest pain (angina), atrial fibrillation, or a history of heart procedures such as bypass surgery or stenting. People with certain abnormal heart electrical readings (QTcF greater than 470 msec) or other factors that raise the risk of serious heart rhythm problems are also excluded (confirm specific details with trial site).
• People who have received a live vaccine within 30 days before starting the study or within 30 days of receiving treatment.
• People with a significant history of neurological or psychiatric conditions — such as psychosis, dementia, or seizures — that would prevent them from understanding and giving informed consent.
• People with any other condition that, in the treating doctor's opinion, could interfere with evaluating the treatment or the person's safety — such as uncontrolled high or very low blood pressure, a significant aneurysm, a previous kidney transplant, or active bleeding conditions.
• People who have had a major surgical procedure within 4 weeks before the first dose of study treatment, or who are expected to need major surgery during the study (placement of a vascular access device is generally excepted — confirm with trial site).
• People currently taking part in another clinical trial that involves receiving an experimental treatment, or who have done so within the 4 weeks before the first dose in this trial. Participation in a non-interventional (observational) study, or being in the follow-up phase of a previous interventional study, may be acceptable (confirm with trial site).

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