Phase 1 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:

• Women aged 18 to 55 years who have never received GnRH (a hormone-suppressing) treatment, or who started GnRH treatment less than 6 months before signing the consent form.
• People with breast cancer that has spread to nearby tissue or other parts of the body, confirmed by a tissue sample (biopsy), where surgery or radiation to cure the cancer is not considered possible by the doctor.
• People whose breast cancer tests positive for hormone receptors — either estrogen receptor (ER+) or progesterone receptor (PR+) — based on laboratory testing of the tumour.
• People whose breast cancer tests negative for a protein called HER2, assessed according to established clinical guidelines.
• People who have previously received radiation therapy for their cancer.
• People who are already taking certain targeted cancer medicines (CDK 4/6 inhibitors or PIK3CA-AKT inhibitors) or bone-strengthening medicines (bisphosphonates), provided these were started at a stable dose at least 2 weeks before joining the trial and are not causing significant side effects.
• People who have not previously received GnRH treatment or other hormone-blocking therapy for advanced or metastatic breast cancer (for those in the GnRH treatment-naïve group).
• People who received a GnRH agonist or other hormone therapy but were confirmed to be premenopausal before starting that treatment, within the 6 months before joining the trial (for those in the GnRH treatment-exposed group).
• People who previously received chemotherapy before or after surgery for early-stage breast cancer, provided their menstrual status meets the trial's premenopausal requirements and chemotherapy side effects have largely resolved.
• People whose side effects from past chemotherapy have settled to mild or minimal levels before joining, with the exception that moderate hair loss, nerve tingling, or numbness may still be present.
• People who are taking certain hormone-blocking medicines (such as aromatase inhibitors, fulvestrant, or similar FDA-approved treatments) at the time of joining.
• People who are able to understand and agree to the trial procedures and are willing to follow the trial requirements.
• People who are either completely abstaining from sexual activity, or using two forms of non-hormonal contraception throughout the trial period, and who have a negative pregnancy test at screening and before starting the trial drug.
• People with a general health and activity level rated as 0, 1, or 2 on the ECOG scale — meaning someone who is fully active, has some limitations but is able to care for themselves, or is able to look after themselves but unable to work (confirm with trial site).

Who may not be able to join:

• Women who have gone through menopause naturally or due to surgery, regardless of age.
• People with a body weight that falls outside the BMI range of 18 to 35 kg/m² (confirm with trial site for exact calculations).
• People who have had both ovaries surgically removed, or who have had radiation treatment directed at the ovaries.
• People who received radiation therapy for breast cancer within the 4 weeks before joining the trial, or whose side effects from radiotherapy have not sufficiently resolved.
• People who have radiotherapy planned during the time they would be participating in the trial.
• People who are taking, or plan to take, tamoxifen or similar medicines known as SERMs during the trial.
• People with a known allergy or serious sensitivity to goserelin, GnRH medicines, or any ingredient in the trial drug.
• People whose doctors estimate their life expectancy to be less than 6 months from when trial treatment would begin.
• People with a general health and activity level rated as 3 or higher on the ECOG scale — meaning those who are mostly confined to bed or chair and have very limited ability to care for themselves.
• People with life-threatening spread of cancer to vital organs, such as extensive liver involvement, serious lung spread, symptomatic fluid around the lungs, or cancer that has spread to the brain and is causing symptoms. (Note: people with brain metastases that are stable, treated, and not causing symptoms may still be considered — confirm with trial site.)
• People with significantly abnormal liver function blood test results, based on specific laboratory thresholds (confirm with trial site).
• People with significantly abnormal kidney function, based on a specific blood test calculation (confirm with trial site).
• People with low blood counts — including low red blood cells (anaemia), low white blood cells, or low platelets — below specific laboratory thresholds (confirm with trial site).
• People who have had another active cancer within the past 3 years, other than certain treated skin cancers or early-stage cervical changes.
• People with a serious, uncontrolled medical or psychiatric condition that the trial doctor believes could interfere with safe participation.
• People who have taken part in another clinical trial involving an experimental drug or device within the 30 days before joining this trial.
• People who are pregnant or have a positive pregnancy test at screening or at the start of the trial.
• People who are currently breastfeeding.
• People who are sexually active with a male partner and are not willing to use non-hormonal contraception throughout the trial (exceptions may apply if the partner has had a vasectomy, or if the participant has had certain permanent contraceptive procedures — confirm with trial site).
• People with certain heart conditions, including a specific abnormality on a heart tracing (QTcF interval greater than 450 ms), severe heart failure, a heart attack within the past 6 months, unstable chest pain, significant irregular heartbeat, or a inherited heart rhythm condition.
• People with abnormal results from physical examinations, heart tracings, or blood tests at the screening stage that the trial doctor believes could affect safety or the trial's goals.
• People with a history of multiple or severe allergic reactions to medicines or foods, or a history of severe anaphylaxis.
• People with a history of alcohol misuse or drug use (including cannabis) within the year before starting the trial drug.
• People who have had major surgery within the 30 days before starting the trial drug, or who have major surgery planned during the trial period.
• People with any other condition that, in the trial doctor's judgement, would prevent safe or proper participation in the trial.

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