Phase 2 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:

• People who have signed a consent form before any trial procedures begin.
• Women who are at least 35 years old at the time of signing the consent form.
• Women who are still having menstrual periods (premenopausal) at the time of joining — either having had a period within the last 6 months, or having hormone levels in the premenopausal range according to lab tests. (Note: women who have had both ovaries surgically removed are not eligible.)
• People with a newly diagnosed, untreated breast cancer that has been confirmed by tissue biopsy as an invasive cancer (adenocarcinoma), that has not spread to other parts of the body, and is at an early enough stage to be operated on (Stage I to IIB).
• People whose breast tumour measures at least 10 mm in its longest dimension, as seen on MRI or ultrasound.
• People whose breast cancer tests positive for oestrogen receptors (ER+, with more than 10% of cells staining positive) and negative for HER2, as confirmed by laboratory testing.
• People whose tumour has a Ki67 score (a measure of how quickly cancer cells are growing) between 10% and 35%, based on local laboratory assessment.
• People who are generally well enough to carry out normal daily activities, with little or no limitation (ECOG performance score of 0 or 1).
• People whose breast cancer is suitable for surgery as the primary treatment.
• People who can provide a stored or freshly taken tumour tissue sample of sufficient quality for biomarker testing before treatment begins.
• People with adequate blood counts and organ function within 14 days before starting treatment, including acceptable levels of white blood cells, haemoglobin, platelets, kidney function, liver function, blood clotting, and electrolytes (such as potassium, calcium, and sodium).
• People who are willing and able to attend all scheduled visits, follow treatment plans, and complete all required tests and procedures.
• Women who could potentially become pregnant must have a confirmed negative blood pregnancy test within 7 days before being assigned to a treatment group.
• Women who could potentially become pregnant must be willing to use highly effective non-hormonal contraception — such as a non-hormonal intrauterine device (IUD) or complete abstinence — throughout the trial and for at least 28 days after the last dose of study treatment. (Note: hormonal contraception such as the pill, patch, implant, or hormonal IUD is not permitted in this trial.)
• Women who could potentially become pregnant must agree not to donate eggs or retrieve eggs for their own use from the start of the trial until at least 120 days after the final dose of study treatment.
• People who are able to swallow oral (tablet/capsule) medication.

Who may not be able to join:

• People with inoperable locally advanced or inflammatory breast cancer (Stage III).
• People with breast cancer that has already spread to other parts of the body (Stage IV / metastatic).
• People who have invasive breast cancer in both breasts at the same time, or in multiple separate areas of the same breast.
• People who need to start chemotherapy or surgery immediately, without delay.
• People who have already had a sentinel lymph node biopsy or surgical removal of the tumour before joining the trial.
• People who have had another cancer in the past 3 years, except for certain fully treated early-stage cancers or non-melanoma skin cancers that are in complete remission (confirm with trial site).
• People currently taking certain medications that cannot be stopped at least 7 days before treatment starts, including: medications that interact with the trial drug triptorelin (decapeptyl); strong blockers of a liver enzyme called CYP3A4; herbal supplements such as St. John's Wort, ginkgo biloba, ginseng, or similar; or those who have received any vaccination (including COVID-19) within 7 days before being assigned to a treatment group.
• People who have already received any treatment — including chemotherapy, hormone therapy, targeted therapy, or radiotherapy — for their currently diagnosed breast cancer.
• People who have had a major surgery or serious injury within 28 days before joining the trial.
• People whom the trial doctor considers unable or unwilling to follow the trial requirements.
• People who have had a serious heart or blood vessel event within the past 6 months, such as a heart attack, severe chest pain, significant heart rhythm problems, a prolonged QT interval on an ECG, uncontrolled irregular heartbeat, heart bypass surgery, moderate-to-severe heart failure, or a stroke or mini-stroke.
• People with moderate or severe liver disease (Child-Pugh Score above Class A).
• People with a blood clotting disorder, or a history of deep vein thrombosis (DVT) or pulmonary embolism (blood clot in the lung) within the past 6 months. (Some exceptions may apply — confirm with trial site.)
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have difficulty swallowing tablets or have conditions that would prevent medication from being properly absorbed, such as severe nausea or vomiting, bowel obstruction, malabsorption conditions, or a history of gastric bypass surgery.
• People with significant other health conditions that, in the trial doctor's judgement, could interfere with the trial or the person's safety.
• People who have used hormonal treatments for other reasons (such as osteoporosis, hormone replacement therapy, or breast cancer prevention — for example, tamoxifen, raloxifene, oestrogen, or progestins) unless those treatments ended at least 12 months before joining the trial. Natural products known to contain progestins must have been stopped at least 14 days before starting treatment.
• People who have taken prescription medications in the past month that the trial doctor believes could interfere with the study or pose additional risks.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial.

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