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 are at least 18 years old, of any gender.
• People who have breast cancer that has spread locally or to other parts of the body, where the cancer tests positive for hormone receptors (ER and/or PgR) and negative for HER2.
• People who have a harmful or likely harmful inherited change (mutation) in the BRCA1 or BRCA2 gene, confirmed by local testing.
• People who are able and willing to provide a stored tumour tissue sample (a small block of preserved tumour material).
• People whose doctor has determined that a PARP inhibitor medication is the appropriate standard treatment for them, and who are planned to receive olaparib.
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale (ECOG performance status 0–2) (confirm with trial site).
• People whose side effects from any previous cancer treatment have mostly resolved before starting the trial (minor lingering effects such as hair loss may be acceptable).
• People whose doctors estimate they are likely to live for more than 6 months.
• People who have signed a written consent form agreeing to take part and to attend scheduled visits and follow-up appointments.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting treatment, and must agree to use highly effective non-hormonal contraception as set out in the study protocol.
• Men must agree to either avoid heterosexual intercourse or use a condom during the treatment period and for at least 120 days after the last dose of one of the study drugs, and must also agree not to donate sperm during this time.

Who may not be able to join:

• People who have a known serious allergic reaction to any of the medicines or ingredients used in this trial.
• People who have active or newly diagnosed cancer that has spread to the brain or the lining of the brain. (Note: people with stable, previously treated brain metastases may be eligible, provided radiotherapy was completed at least one week before the planned trial start date.)
• People who have serious, life-threatening symptoms from cancer that has spread to internal organs — for example, large uncontrolled fluid build-up, cancer spread throughout the lungs' lymph vessels, or severe liver involvement.
• People whose blood test results show that the liver, kidneys, or blood cell counts are not working well enough before joining — including low red blood cells, low white blood cells, low platelets, or abnormal liver or kidney function markers (confirm specific thresholds with trial site).
• People who have a medical reason that prevents them from safely taking elacestrant or olaparib.
• People who have previously been treated with a PARP inhibitor medication.
• Women who are pregnant or breastfeeding at the time of joining, or who plan to become pregnant during the study or for a set period after treatment ends.
• Men who plan to father a child during the study or for a set period after treatment ends.
• 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, heart failure, stroke, or a mini-stroke (TIA).
• People who have high blood pressure that has not been adequately controlled at the time of screening (above 140/90 mmHg).
• People who are currently taking blood-thinning medication to treat a blood clot that occurred within the past 6 months. (Preventative blood-thinning treatment may be acceptable — confirm with trial site.)
• People who have difficulty swallowing or absorbing oral (tablet/capsule) medications — for example, due to severe nausea or vomiting, a bowel blockage, a malabsorption condition, or a history of gastric bypass surgery.
• Women who have a history of abnormal uterine lining cells (endometrial intraepithelial neoplasia) and have not had a hysterectomy.
• People who have or have had another cancer within the past 5 years (some exceptions apply, such as certain early-stage skin cancers or cervical changes — confirm with trial site).
• People who have uncontrolled active infections, including hepatitis B, hepatitis C, or HIV. Some exceptions may apply depending on test results — confirm with trial site.
• People who have a serious uncontrolled medical or psychiatric condition that the doctor considers would make participation unsafe or affect the reliability of trial results.
• People who have a significant history of neurological or psychiatric conditions — such as psychotic disorders, dementia, or seizures — that would prevent them from fully understanding and consenting to the trial.
• People who are unable or unwilling to stop taking certain medications, herbal supplements (such as St. John's Wort), or foods (such as grapefruit, pomegranate, star fruit, or Seville oranges) that can interfere with how the study drugs work, unless these have been stopped for at least 14 days before starting the trial and can be avoided throughout.
• People who are currently taking part in another clinical trial involving an experimental drug, or who have done so within the past 30 days.
• People who have received a live vaccine within 30 days before joining the trial. (COVID-19 vaccines that do not contain a live virus are generally acceptable if given at least one week before the trial starts.)

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