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 between the ages of 18 and 80 who have been diagnosed with breast cancer that has spread to other parts of the body (confirmed by lab tests or scans), where surgery or radiation to cure the disease is not an option
• People whose breast cancer has been confirmed by lab testing to be hormone receptor positive (ER and/or PR positive) and HER-2 positive, based on specific laboratory thresholds
• People who are post-menopausal, or pre-menopausal people who have had both ovaries removed or are receiving specific hormone-suppressing medication
• People whose cancer did not progress until more than 12 months after finishing their last course of trastuzumab (a targeted cancer drug)
• People who have either never received trastuzumab for metastatic disease, or who have only received one course of trastuzumab-based treatment for metastatic disease, and for whom trastuzumab was found to be effective during that first treatment attempt
• People who have previously received chemotherapy and/or hormone therapy (either before or after surgery, or for metastatic disease), and whose cancer has continued to grow during or after that treatment
• People who are in reasonably good general health, rated 0–2 on the WHO physical status scale, with an expected survival of at least 3 months
• People who have at least one area of cancer that can be measured on a scan, based on specific size requirements, within the 2 weeks before joining the trial
• People whose side effects from past treatments have mostly resolved to a mild or minimal level (with some exceptions, such as hair loss, as judged by the treating doctor)
• People whose recent blood test results (within one week before joining) show white blood cell, neutrophil, and platelet counts within acceptable ranges
• People whose recent liver, kidney, and heart function test results (within one week before joining) are within acceptable ranges, including liver enzymes, bilirubin, creatinine, heart pumping function (LVEF), and heart rhythm measurements

Who may not be able to join:

• People who have not previously received trastuzumab, chemotherapy, and hormone therapy
• People who have cancer that has spread to the brain or central nervous system and are experiencing symptoms from it
• People experiencing a life-threatening crisis caused by cancer that has spread to internal organs
• People who the treating doctor considers suitable for chemotherapy
• People who have significant difficulties swallowing, ongoing severe diarrhoea, or a blocked bowel, which could affect how medication is absorbed
• People who have received radiotherapy, chemotherapy, hormone therapy, surgery (other than minor procedures such as a biopsy), or targeted therapy within 4 weeks before joining the trial
• People who have taken part in another clinical trial within the 4 weeks before joining
• People who have received more than one line of hormone therapy, chemotherapy, or targeted therapy for their metastatic disease
• People who have had another cancer in the past 5 years, with the exception of certain treated skin cancers or cervical carcinoma in situ that have been fully cured
• People who are currently receiving any other cancer treatment at the same time
• People with a known allergy to any components of the trial medications, a history of immune system disorders (including HIV, hepatitis C, or active hepatitis B), or a history of organ transplantation
• People with serious heart conditions, including a history of heart failure, certain uncontrolled abnormal heart rhythms, or significantly high blood pressure
• People who are pregnant, breastfeeding, or people of childbearing potential who have a positive pregnancy test at the start of the trial
• People with a known history of neurological or psychiatric conditions, including epilepsy or dementia
• People with other serious ongoing illnesses or conditions that the treating doctor believes could put them at risk or interfere with the trial, including uncontrolled infections or uncontrolled heart or blood pressure conditions

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