Phase 2 Breast 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:

• You are 18 years of age or older and have been diagnosed with invasive breast cancer confirmed by a tissue biopsy
• Your breast cancer has been confirmed as triple-negative breast cancer (TNBC), based on the most up-to-date testing guidelines
• You have a confirmed inherited (germline) mutation in the BRCA1 or BRCA2 gene
• Your TNBC is locally advanced but has not spread to other parts of the body (non-metastatic), and falls into a specific category of tumor and lymph node size as assessed by your doctor
• Tests have confirmed that the cancer has not spread to distant organs such as the chest, abdomen, or bones (brain scans may not be required if you have no symptoms)
• You are generally able to carry out daily activities with little to no limitation (confirm with trial site)
• Your liver, kidneys, and other organs are functioning well enough, based on blood tests taken within 10 days before starting treatment
• You are willing and able to give written consent to take part in the trial

Who may not be able to join:

• You have a positive pregnancy test taken within 72 hours before registering for the trial
• You have been diagnosed with inflammatory breast cancer
• You have previously been treated with certain immune checkpoint drugs (such as anti-PD-1 or anti-PD-L1 therapies) or similar immune-targeting treatments
• You have received a live or live-attenuated vaccine (such as certain flu or shingles vaccines) within the past 30 days
• You are currently taking part in, or have recently taken part in, another clinical trial or used an experimental device within the past 4 weeks
• You have a condition that weakens your immune system, or you have been taking steroid tablets or other immune-suppressing medicines within the past 7 days
• You have a history of another cancer, unless you completed treatment more than 2 years ago with no signs of it returning
• You have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or other drugs used in this study
• You have an active autoimmune disease (where the immune system attacks the body) that has needed treatment in the past 2 years
• You have a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease) that was not caused by infection
• You currently have an active infection that requires medication
• You have a known history of HIV
• You have a known history of active Hepatitis B or Hepatitis C infection
• You have a known history of active tuberculosis (TB)
• You have a current or past condition, treatment, or abnormal test result that may affect your safety or the trial results (confirm with trial site)
• You have a known psychiatric illness or substance use disorder that could affect your ability to participate in the trial
• You are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial
• You have previously had an organ or tissue transplant from another person
• You have previously been treated with Olaparib or any other PARP inhibitor medication
• You have significant heart disease
• Your resting heart tracing (ECG) shows an uncontrolled heart condition that could potentially be treated (confirm with trial site)
• You have or show signs of certain serious blood or bone marrow disorders (MDS or AML)
• You have received certain blood cell-stimulating injections within the past 28 days
• You have a serious, uncontrolled medical condition or active uncontrolled infection that puts you at high medical risk
• You are unable to swallow tablets or capsules, or have a digestive condition that affects how your body absorbs medication
• The trial team believes you may be unable to follow the trial procedures and requirements
• You are currently taking certain medications that strongly or moderately affect how the body processes a specific liver enzyme (CYP3A4), and these cannot be stopped for the duration of the trial

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