Phase 3 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 diagnosed with HER2-positive endometrial cancer (including serous, clear cell, endometrioid, mixed, dedifferentiated/undifferentiated types, or carcinosarcoma) at any stage (IA through IVB), where the cancer has not come back and no chemotherapy has been given yet.
• People whose cancer does NOT have a specific DNA repair fault called "mismatch repair deficiency" (dMMR) — testing is required to confirm this.
• People whose diagnosis has been confirmed by a pathology report from surgery or a biopsy.
• People who are registering within 8 weeks of their surgery or biopsy.
• People whose cancer, if confined to the uterus (stage I), has grown into the muscular wall of the uterus (any depth of invasion counts, but surface-only or polyp-confined disease does not qualify).
• People whose tumour tests positive for HER2 using recognised laboratory methods (IHC 3+, or IHC 2+ with a positive ISH test, or through a type of genetic sequencing test called NGS showing HER2 amplification).
• People aged 18 or older.
• People with a general health/activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities, even if limited).
• People whose recent blood tests (taken within 14 days before joining) show platelet counts, white blood cell counts, kidney function, liver enzymes, and bilirubin levels all within the ranges required by the trial (confirm specific values with the trial site).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the last 6 months.
• People who are not able to become pregnant, or people of childbearing potential who have a negative pregnancy test before joining.
• People with a history of another cancer, as long as that cancer or its treatment is not expected to interfere with this trial.
• People with chronic hepatitis B who are on suppressive therapy and have an undetectable viral load.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who have had brain metastases that were treated, and whose follow-up brain scans show no sign of the cancer growing back in the brain.
• People (or their legal representative) who are willing and able to give informed consent before joining the trial.

Who may not be able to join:

• People who have previously received chemotherapy, biological therapy, or targeted therapy for endometrial cancer.
• People who have previously received radiation therapy for endometrial cancer (including external beam radiation or internal radiation called brachytherapy) — note that vaginal brachytherapy given during the trial may be permitted if declared at registration (confirm with trial site).
• People who have plans for further surgery (such as a hysterectomy or tumour-reducing operation) or external beam radiotherapy before any sign of the cancer progressing, after joining the trial.
• People with serious heart conditions, including poorly controlled high blood pressure, a heart attack or unstable chest pain within the past 6 months, moderate-to-severe heart failure, or a significant heart rhythm problem requiring medication.
• People with significant lung problems, such as breathlessness at rest, moderate-to-severe lung inflammation, certain lung diseases (including pulmonary fibrosis, cystic fibrosis, or active tuberculosis), or a history of specific serious lung infections.
• People with uncontrolled ongoing illness, including active infections (other than a straightforward urinary tract infection), uncontrolled lung disease, severe heart failure, or mental health or personal circumstances that would make it difficult to follow the trial requirements.
• People currently taking certain strong medications that affect how the body processes drugs (strong CYP2C8 or CYP3A4 inhibitors or inducers) within a set period before joining (confirm timing with trial site).
• People who are currently breastfeeding and are unwilling to stop.

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