Phase 3 Ovarian 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:

• The patient or their legal representative must agree to take part and sign a consent form before joining.
• Patients must be female and 18 years of age or older.
• Patients must be premenopausal (ovaries still functioning) at the time of joining — this is assessed based on age, recent menstrual periods, and/or hormone level blood tests (confirm with trial site for exact requirements).
• Patients must be well enough to carry out basic daily activities, as measured by standard health performance scales (confirm with trial site).
• Patients who have a second breast cancer in either breast at the same time may be eligible, as long as the most advanced tumour meets the trial's requirements and the other cancer sites would not require chemotherapy or HER2-targeted treatment.
• Patients with cancer in multiple areas of the same breast may be eligible, as long as the most advanced tumour meets the trial's requirements and the other areas would not require chemotherapy or HER2-targeted treatment.
• Patients who have had a full mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy (partial removal) are eligible.
• For patients who had a lumpectomy, the edges of the removed tissue must be clear of cancer cells, with no cancer at the cut margins as confirmed by a pathologist (certain exceptions apply — confirm with trial site).
• For patients who had a mastectomy, the surgical margins must be free of visible remaining tumour (patients with microscopic positive margins may be eligible if chest wall radiation therapy is planned).
• Patients must have had the lymph nodes under the arm assessed through one of the accepted surgical methods.
• Based on pathology results, the tumour must be a specific stage: primary tumour classified as pT1–pT3, and lymph nodes either clear (pN0) or with limited spread (pN1), according to standard staging guidelines.
• Patients must have a specific score on a gene test called the Oncotype DX Recurrence Score (RS): if lymph nodes are clear, the score must be 21–25, or 16–20 with certain tumour characteristics; if 1–3 lymph nodes are involved, the score must be below 26 (confirm with trial site for full details).
• Patients who had a MammaPrint "Low Risk" or "MP1" result must have an Oncotype DX RS test done before joining; patients with a MammaPrint "High Risk" or "MP2" result are not eligible.
• The tumour must test positive for oestrogen receptors (ER) and/or progesterone receptors (PgR), meaning the cancer is hormone-sensitive.
• The tumour must test negative for HER2, a specific protein that can affect how cancer grows.
• No more than 16 weeks must have passed between the last breast surgery and joining the trial.
• A short course of hormone therapy (less than 6 weeks) taken before joining is acceptable, either before or after surgery.
• Patients with a previous or current non-breast cancer whose history or treatment would not interfere with this trial may be eligible, including those previously treated with the aim of cure.
• Patients living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months may be eligible.
• Any planned radiation therapy must follow standard guidelines and must be declared before joining.

Who may not be able to join:

• Patients with clear clinical or imaging evidence that cancer has spread to other parts of the body (metastatic disease).
• Patients with a pT4 tumour, including inflammatory breast cancer.
• Patients with a history of invasive breast cancer in either breast (patients with a previous or current non-invasive breast cancer such as DCIS or LCIS may still be eligible).
• Patients who previously had DCIS in the same breast treated with lumpectomy and radiation therapy must have had a full mastectomy for the current cancer to be eligible.
• Patients whose life expectancy is estimated to be less than 10 years due to other health conditions.
• Patients whose recent routine blood test results show any of the following: low white blood cell count (ANC below 1200/mm³), low platelet count (below 100,000/mm³), low haemoglobin (below 10 g/dL), elevated bilirubin levels beyond normal limits (with some exceptions), elevated liver enzyme levels, or significantly reduced kidney function.
• Patients with known heart disease or a history of treatment with heart-toxic medications who are assessed as having moderate-to-severe heart function problems (above Class 2B on the New York Heart Association scale).
• Patients whose breast cancer is a non-epithelial type, such as sarcoma or lymphoma.
• Patients who have already received radiation therapy, chemotherapy, or biotherapy for their current breast cancer diagnosis are not eligible; patients who had more than 6 weeks of hormone therapy for this cancer before joining are also not eligible (prior tamoxifen for cancer prevention, or prior hormone therapy for fertility preservation, is allowed).
• Patients currently using hormone-based contraception, including hormonal or progestin/progesterone-releasing IUDs, must have stopped use before joining.
• Patients with an active or chronic hepatitis B virus (HBV) infection are not eligible unless the virus is undetectable on suppressive treatment; patients with a history of hepatitis C virus (HCV) are not eligible unless they have been successfully treated and cured, or have an undetectable viral load if still on treatment.
• Patients who are pregnant or breastfeeding at the time of joining (pregnancy testing must be done within 2 weeks before joining, in line with standard practice).
• Patients with other conditions that, in the opinion of the trial doctors, would prevent them from meeting the study requirements or affect the results.

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