Phase 2 Ovarian 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:

• People aged 18 or older but under 50 years old
• People who have been diagnosed with localised or locally advanced hormone-positive breast cancer (Stage I–III), confirmed by laboratory testing of tissue or cell samples, who have completed treatment aimed at curing the cancer and are currently in remission
• People who have been receiving ovarian function suppression (a treatment to reduce hormone levels) using a monthly goserelin injection in the abdomen, plus either an aromatase inhibitor or tamoxifen, for at least 6 months before joining the study — with a plan to continue this treatment for at least the next 12 months
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (confirm with trial site)
• People who are willing and able to sign a consent form agreeing to take part
• People who are able to complete questionnaires on their own or with help
• People who agree to provide blood samples for research purposes as required by the trial
• People who are willing to return to the enrolling clinic for follow-up visits during the active part of the study
• People who have a negative pregnancy blood test within 14 days before registering, and a negative pregnancy urine test within 7 days before being assigned to a treatment group
• People who are sexually active, along with their partners, who agree to use a reliable form of contraception from before the study starts, throughout participation, and for at least 3 months after the last dose of study medication — acceptable methods include the oral contraceptive pill, condom with spermicide, diaphragm with spermicide, surgical sterilisation of either partner, being more than 12 months past menopause, or an injectable or implantable contraceptive device. Male participants should avoid donating sperm, and female participants should avoid breastfeeding during this time
• People who, after completing 6 cycles of the lead-in ovarian function suppression treatment, have hormone (estradiol) levels below a specified threshold, indicating the treatment is working as required (confirm specific level details with trial site)

Who may not be able to join:

• People who have received chemotherapy within the 6 months before registering (note: some other treatments such as HER2-targeted therapies, endocrine therapy, or CDK 4/6 inhibitors may still be permitted — confirm with trial site)
• People who are currently taking any medications containing oestrogen or progestins, including creams or gels applied to the skin
• People who are planning to stop their ovarian function suppression treatment, either temporarily or permanently, within the next 12 months

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