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:

• Women aged 18 to 75 with advanced breast cancer that has been confirmed by pathology testing, where surgery or radiation aimed at curing the cancer is not suitable.
• People whose tumour testing shows it is hormone receptor positive (ER and/or PR positive) and HER-2 negative, based on specific laboratory results.
• People whose advanced breast cancer did not get worse during 4 to 8 cycles of first-line chemotherapy — meaning the cancer responded or stayed stable. (Those who received capecitabine alone as first-line chemotherapy are also eligible, with treatment limited to 6 cycles.)
• People with a good general physical condition, rated 0 or 1 on the WHO performance scale, and with a life expectancy of at least 3 months.
• People who have had imaging scans to assess their tumours within 3 weeks before joining the trial.
• People whose side effects from previous treatment have mostly resolved to a mild level (Grade 1 or lower) before the trial begins, with some exceptions such as hair loss.
• People with normal blood count results within 1 week before joining, meeting specific levels for white blood cells, neutrophils, and platelets.
• People with normal liver and kidney function results within 1 week before joining, meeting specific laboratory thresholds.
• People who have signed an informed consent form before enrolling.

Who may not be able to join:

• People with newly diagnosed spread of cancer to the brain, or whose brain metastasis symptoms have been controlled for less than 4 weeks. (People with brain metastases that cause no symptoms, have been stable for more than 4 weeks on imaging, and do not require steroid treatment may still be considered.)
• People diagnosed with another cancer in the 3 years before joining, except for certain treated skin cancers or cervical cancer in situ.
• People who have already received hormone (endocrine) therapy for their advanced breast cancer.
• People who are pregnant or currently breastfeeding.
• People with serious ongoing health conditions that could interfere with the study or affect their safety, such as uncontrolled heart disease, uncontrolled high blood pressure, an active or uncontrolled infection, or active hepatitis B.
• People who were found unable to tolerate the side effects of capecitabine during their first-line chemotherapy.
• People whose cancer came back or spread within 2 years of completing adjuvant (post-surgery) hormone therapy.

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