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 diagnosed with a specific type of breast cancer called invasive ductal carcinoma (or a closely related type), but not the sarcomatous, signet cell, or metaplastic subtypes
• People whose breast cancer has been staged as Stage IIB or Stage III — or Stage IIA if the cancer is triple negative or HER2-positive breast cancer — based on standard staging guidelines (not including inflammatory breast cancer)
• People whose breast lump can be felt by their treating doctor during a physical examination
• People whose treatment plan includes chemotherapy given before surgery (called neoadjuvant chemotherapy)
• People who are able to tolerate a core needle biopsy procedure and an injection of a drug called pembrolizumab
• People aged 18 or older
• People who are able to understand and agree to participate by signing an informed consent form

Who may not be able to join:

• People with serious health conditions or other medical reasons that would make radiation therapy, chemotherapy, or surgery unsafe (for example, uncontrolled diabetes or a serious heart condition)
• People who have already received any treatment for their current breast cancer diagnosis
• People who have previously had radiation therapy to the same breast
• People diagnosed with inflammatory breast cancer
• People whose breast cancer is of the sarcomatous, signet cell, or metaplastic subtype
• People whose breast cancer has come back after a previous diagnosis (recurrent breast cancer)
• People where there is any sign or suspicion — based on physical examination or imaging — that the cancer has spread to other parts of the body
• People with certain connective tissue or autoimmune conditions (such as lupus, scleroderma, dermatomyositis, or psoriatic arthritis) that the treating radiation specialist determines would make radiation therapy unsafe
• People who have previously had a stem cell transplant
• People with any poorly controlled autoimmune conditions
• People currently taking corticosteroids or immunosuppressant medications
• People who have had another cancer (other than certain common skin cancers) within the 5 years before enrolling in the study — though having cancer in both breasts at the same time is acceptable
• People who are unable to tolerate core needle biopsies or the pembrolizumab injection
• People who are currently pregnant or breastfeeding
• People under 18 years of age
• People who are unable or unwilling to provide informed consent
• People who are unable or unwilling to complete the study's required assessments, procedures, and follow-up visits

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