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:

• Women aged 18 or older who have been confirmed by tissue testing to have triple negative breast cancer (TNBC) or a type of breast cancer that is estrogen receptor positive (ER+) and HER-2 negative
• People whose general health and ability to carry out daily activities is rated at 0 or 1 on a standard medical scale (meaning fully active or able to do light work), assessed within the 30 days before joining the trial
• People whose TNBC or ER+ breast cancer has spread to other parts of the body or has come back after earlier treatment
• People with metastatic TNBC who have previously received immunotherapy treatment and whose cancer progressed on it, or whose cancer tests negative for a protein called PD-L1
• People who have received no more than 3 prior rounds of treatment for metastatic TNBC (treatments stopped due to side effects rather than disease progression do not count toward this limit); any number of prior treatments is allowed for metastatic ER+ breast cancer
• People who have at least one area in the body where palliative radiation therapy (radiation to relieve symptoms) would be considered appropriate by the treating doctor
• People who are able to provide a tissue sample from their tumour, either from a previous biopsy or a new one taken up to 30 days before starting treatment
• People who have measurable disease — meaning at least one tumour that can be seen and measured on imaging scans, located outside of bone, and not planned to receive radiation therapy as part of this trial
• People who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use reliable contraception during treatment and for at least one month after the last dose
• People whose blood test results show that their kidneys, liver, blood cell counts, and blood clotting are all within acceptable ranges, tested within 30 days before starting treatment
• People who are able to swallow tablets or capsules whole and keep them down
• People taking corticosteroid medication whose dose has been stable for at least 4 weeks before starting the trial

Who may not be able to join:

• People with metastatic TNBC who have received more than 3 prior lines of systemic treatment
• People who have a positive pregnancy test result within the required timeframe before starting treatment
• People who received anti-cancer treatment less than 2 weeks before starting the trial (a 4-week gap is preferred), or who have not recovered from side effects of previous treatments (minor nerve-related side effects of grade 2 or below may still be acceptable — confirm with trial site)
• People who received radiation therapy less than 2 weeks before starting the trial, or who have not recovered from radiation side effects, or who have had radiation-related lung inflammation
• People who previously experienced severe (grade 3 or higher) immune-related side effects from immunotherapy
• People who received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or typhoid) within 30 days before the first dose; injected flu vaccines are generally allowed, but nasal spray flu vaccines are not
• People currently participating in, or who have participated in, another clinical trial using an experimental treatment within the past 2–4 weeks
• People with a known immune deficiency, or who are taking high-dose steroid medication (more than the equivalent of 10 mg of prednisone per day) or other immune-suppressing drugs within 7 days before starting the trial
• People who have another cancer that is currently active or has required treatment within the past 2 years (certain skin cancers and carcinoma in situ that have been treated with curative intent are generally not excluded — confirm with trial site)
• People who have had a severe allergic reaction (grade 3 or higher) to pembrolizumab, olaparib, or any of their ingredients
• People with an autoimmune disease that has required systemic medical treatment in the past 2 years (hormone replacement therapies for conditions like thyroid deficiency are generally not considered exclusionary — confirm with trial site)
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People with an active infection that requires treatment
• People with a known history of HIV
• People with known active Hepatitis B or Hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People with a known psychiatric illness or substance use disorder that would interfere with participation in the trial
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for 120 days after the last dose
• People who have previously received a transplant of tissue or a solid organ from another person
• People with certain serious or uncontrolled heart conditions, including unstable heart disease, uncontrolled abnormal heart rhythms, heart failure, a significantly prolonged heart electrical reading (QTcF above 500 ms), or a genetic condition called long QT syndrome
• People with ongoing side effects from previous cancer treatment rated above grade 2 in severity (hair loss is not included in this restriction)
• People with a blood or bone marrow condition called myelodysplastic syndrome or acute myeloid leukaemia, or test results suggesting these conditions
• People with brain metastases that are causing symptoms and are not under control; people with spinal cord compression that has not been definitively treated and shown to be stable for at least 28 days
• People considered to be at serious medical risk due to uncontrolled medical conditions, such as uncontrolled abnormal heart rhythms, a heart attack within the past 3 months, uncontrolled seizures, or certain other serious conditions
• People who are unable to swallow oral medications or who have gut or digestive conditions likely to affect absorption of the trial medications
• People currently taking certain medications that strongly or moderately affect how the body processes olaparib (a drug used in this trial), including specific antifungals, antibiotics, heart medications, and antiviral drugs — a washout period is required before starting the trial (confirm specific medications and washout periods with the trial site)
• People currently taking certain medications that reduce how well olaparib works in the body, including specific seizure medications, antibiotics, and herbal supplements such as St John's Wort — a washout period is required (confirm specific medications and washout periods with the trial site)
• People who have had major surgery within 2 weeks before starting the trial, or who have not fully recovered from surgery
• People who have previously had a bone marrow transplant from another person, or a double umbilical cord blood transplant
• People who have previously been enrolled in this same trial

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