Phase 3 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 written consent form before any trial procedures begin (if someone is physically unable to sign, a trusted person of their choice may confirm consent in writing on their behalf)
• People aged 18 or older
• People who are reasonably active and able to care for themselves, with only limited or no restriction in physical activity (as assessed by a standard medical scale called ECOG, scores 0–2)
• People diagnosed with stage II or stage III breast cancer, confirmed through tissue testing
• People whose breast cancer tests show very low or no estrogen receptor (ER) activity, very low or no progesterone receptor (PR) activity, and no HER2 protein — known as triple-negative breast cancer; in cases of cancer in both breasts, both tumours must meet these criteria
• People who previously received at least 6 cycles of chemotherapy combined with a drug called pembrolizumab before surgery, with all chemotherapy completed before the operation
• People who had no remaining invasive cancer found in the breast or lymph nodes after completing pre-surgery treatment (small amounts of a non-invasive cell change called DCIS are permitted)
• People who have had surgery to fully remove all visible cancer from the breast and nearby lymph nodes, with clear margins confirmed by lab testing, and who also had lymph node assessment (either sentinel node biopsy or full lymph node removal)
• People who have received, or have a plan in place to receive, radiation therapy to the breast area after surgery
• People whose blood and organ function results fall within the required ranges on lab tests taken within 28 days before joining the trial (this covers blood cell counts, kidney function, liver function, and related measures — the trial site can confirm the specific thresholds)
• People who are enrolled into the trial within 12 weeks of their breast surgery
• People who are not pregnant and not breastfeeding; women who could become pregnant must have a negative pregnancy blood test within 7 days of starting the trial
• People who agree to use at least one effective form of contraception during the trial and for up to 4 months after the last dose of study medication (this applies to both women who could become pregnant and male participants)
• People who are willing and able to attend all required trial visits and follow the trial procedures
• People who are members of a Social Security system or equivalent (this appears to be a French regulatory requirement — confirm with the trial site)

Who may not be able to join:

• People whose cancer has spread to other parts of the body (stage IV/metastatic disease), confirmed by scans or physical examination
• People whose cancer has come back after pre-surgery treatment and surgery
• People who have previously had invasive breast cancer in either breast at any point in the past
• People who have, or have had, another type of cancer (other than the current breast cancer) where that cancer or its treatment could affect the safety or results of this trial
• People whose pembrolizumab treatment was permanently stopped during the pre-surgery phase because of a serious side effect caused by that drug
• People who have previously had a severe allergic or infusion reaction (grade 3 or 4) to pembrolizumab or to any of its ingredients
• People who require ongoing use of steroid medication above a certain dose (more than 10 mg prednisone or equivalent per day) or other immune-suppressing medications in the past 2 years (standard hormone replacement therapies such as thyroid medication or insulin are not included in this restriction)
• People with a known active liver disease, such as hepatitis B, hepatitis C, autoimmune liver conditions, or a bile duct condition called sclerosing cholangitis
• People living with HIV who have a detectable level of virus in their blood within 6 months before joining, even if on treatment
• People with a known history of heart disease or prior treatment with heart-affecting drugs, whose heart function is assessed as below a certain level using a standard heart classification scale (confirm specific threshold with the trial site)
• People who are unable or unwilling to attend the required medical follow-up visits for any reason, including geographic, family, social, or personal circumstances
• People who are under legal custody, protective supervision, or guardianship
• People who have participated in another treatment trial within the 30 days before joining this trial

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