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 18 and 70 years of age
• People who are generally well enough to carry out daily activities with little to no limitation (as measured by a standard medical scoring system called ECOG, with a score of 0 or 1)
• People whose breast cancer was diagnosed at a stage that met guidelines for receiving treatment before surgery (neoadjuvant therapy), based on specific staging criteria (confirm with trial site)
• People whose breast cancer has been confirmed by a tissue sample (biopsy) to be hormone receptor-positive (meaning the cancer responds to hormones like estrogen or progesterone) and HER2-positive (meaning the cancer has high levels of a specific protein called HER2)
• People who completed at least 4 cycles of pre-surgery treatment including the drugs trastuzumab and pertuzumab, with little or no cancer remaining after surgery (classified as residual cancer burden class 0 or I), and whose surgery took place no more than 12 weeks before joining the trial
• People whose blood test results within 2 weeks before screening show that the blood cells, liver, and other organs are functioning within acceptable ranges, without needing recent blood transfusions or growth factor support (confirm specific values with trial site)
• People whose heart scan after pre-surgery treatment shows the heart is pumping well enough (left ventricular ejection fraction of 50% or more, or 55% or more if no pre-treatment heart scan was done)
• People who are expected to live at least 6 months or more
• People who are able and willing to use effective non-hormonal contraception, or to abstain from sexual activity, during treatment and for 8 weeks after the last dose (applies to those who could become pregnant)
• People who are willing to participate voluntarily, sign a consent form, follow the study instructions, and attend follow-up appointments

Who may not be able to join:

• People who have had a previous local or regional return of breast cancer
• People whose breast cancer has spread to other parts of the body (stage IV or metastatic)
• People who have cancer in both breasts
• People who have been diagnosed with another cancer in the past 5 years, except for certain treated skin cancers or cervical carcinoma in situ (confirm with trial site)
• People who have previously been treated with certain targeted cancer drugs, including pyrotinib, lapatinib, neratinib, trastuzumab emtansine, or other similar biological or immunotherapy treatments
• People who are currently taking part in another clinical trial that involves any cancer treatment, including hormone therapy or bone-strengthening medication
• People with significant heart problems, such as heart failure, poorly controlled irregular heartbeats, chest pain requiring medication, serious heart valve disease, evidence of a past heart attack on an ECG, or high blood pressure that cannot be controlled with medication
• People who have difficulty swallowing, a bowel blockage, or other digestive conditions that may prevent the body from absorbing medication properly
• People with a history of neurological or psychiatric conditions that may affect their ability to follow the study requirements or provide informed consent
• People with ongoing digestive conditions that cause frequent diarrhoea
• People with a known allergy to any of the study drugs, a history of immune system disorders (such as HIV), or who have had an organ transplant
• People who are pregnant, breastfeeding, or who have a positive pregnancy test at the start of the study
• People with serious ongoing illnesses, including active infections such as hepatitis B, hepatitis C, tuberculosis, or syphilis, or any other condition the trial doctor considers would make participation unsafe

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