Phase 3 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:

• People who have signed an informed consent form agreeing to take part in the study.
• Women aged 18 or older at the time of signing the consent form.
• People who have the ability to understand the study requirements and are willing to follow the treatment and check-up schedule.
• People whose breast cancer has been confirmed as invasive by a tissue biopsy.
• People whose cancer was at a specific stage when first diagnosed (certain combinations of tumour size and lymph node involvement, without spread to other parts of the body — confirm exact staging with trial site).
• People whose breast cancer has been confirmed as triple-negative (TNBC) and has been tested for specific immune markers (TLS and PD-L1) through a central laboratory review of tumour tissue.
• People with cancer in both breasts at the same time, or tumours in more than one area of the breast, may be eligible if all tumours are confirmed by the central laboratory as TNBC and positive for a specific immune marker (TLS).
• People with multiple tumours in the same area of the breast, where at least one tumour has been confirmed by the central laboratory as TNBC and TLS-positive.
• People whose cancer has been confirmed as TNBC and where a specific immune marker (TLS) has been assessed in the tumour tissue before joining the study, using laboratory staining techniques.
• People who have already completed pre-surgery chemotherapy and treatment with a drug called camrelizumab.
• People whose cancer did not fully disappear (did not achieve complete pathological response) after pre-surgery treatment.
• People who had surgery that removed all detectable cancer in the breast and lymph nodes.
• People whose surgery took place no more than 12 weeks before the date of joining the study.
• People who are reasonably active and able to carry out daily activities, based on a standard activity scale (score of 0 or 1 on the ECOG scale).
• People whose heart is pumping well enough, as shown by a heart scan during screening, with specific measurements meeting required thresholds (confirm details with trial site).
• People with a life expectancy of at least 6 months.
• People with blood counts and organ function within acceptable ranges.
• People who test negative for HIV during screening, or who test positive but are on stable HIV treatment, have acceptable immune cell counts, undetectable virus levels, and no serious HIV-related infections in the past 12 months (confirm with trial site).
• People who test negative for hepatitis B during screening.
• People who test negative for hepatitis C antibodies during screening, or who test positive for hepatitis C antibodies but have no detectable hepatitis C virus in their blood.
• People of childbearing potential who agree to use contraception or abstain from heterosexual intercourse during the study, and who agree not to donate eggs.

Who may not be able to join:

• People whose breast cancer has spread to other parts of the body (stage IV/metastatic).
• People who did not have complete surgical removal of all detectable cancer.
• People whose cancer was assessed as getting worse (progressing) at the end of pre-surgery treatment.
• People who need radiation therapy for their breast cancer but cannot receive it for medical reasons (such as certain connective tissue diseases or prior radiation to the same breast).
• People who have had another cancer in the last 5 years, with some exceptions such as certain early-stage or non-invasive cancers (confirm specifics with trial site).
• People who have previously been treated with certain types of immune therapy drugs, including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or CD137-stimulating drugs.
• People who currently have moderate or severe nerve damage in their hands or feet (grade 2 or higher peripheral neuropathy).
• People who experience shortness of breath while at rest.
• People who have heart or lung problems that affect normal function.
• People with a current or past history of autoimmune disease (where the immune system attacks the body) or immune deficiency conditions.
• People with certain lung conditions, including pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or currently active pneumonia.
• People with active tuberculosis.
• People with severe, uncontrolled conditions such as significant heart disease, lung disease, metabolic disorders, poor wound healing, or ulcers.
• People with known active liver disease, such as autoimmune hepatitis or sclerosing cholangitis.
• People who had major surgery (other than their breast cancer surgery) within 4 weeks before joining the study, or who are expected to need major surgery during the study.
• People who had a serious infection within 4 weeks before joining the study, including hospitalisation due to infection, blood poisoning, severe pneumonia, or COVID-19, or any active infection considered a risk to their safety.
• People who received antibiotics by injection within 2 weeks, or oral antibiotics within 5 days, before joining the study.
• People who have had a bone marrow or organ transplant from another person.
• People who have a condition, abnormal test result, or other medical reason that would make the experimental drugs unsafe or make the study results difficult to interpret.
• People who received a live vaccine within 4 weeks before joining the study, or who expect to need one during the study or within 5 months after finishing treatment.
• People who received any experimental treatment within 28 days before joining the study.
• People who received immune-boosting treatments (such as interferons or IL-2) within 4 weeks before joining, or within 5 half-lives of that drug, whichever is longer.
• People who received immune-suppressing medications (such as steroids or certain other drugs) within 2 weeks before joining, or who are expected to need them during the study.
• People who have had a severe allergic reaction to certain types of antibody-based medicines in the past.
• People with a known severe allergy to any ingredient in the study drugs.
• People who are pregnant, breastfeeding, or planning to become pregnant within 6 months after finishing study treatment.

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