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:

Experimental Arm (new treatment being tested):

• People who have given written informed consent before any trial procedures begin (if a person is physically unable to sign, a trusted person of their choice may confirm consent in writing)
• People aged 18 or older at the time of signing the consent form
• People with a confirmed laboratory diagnosis of triple-negative breast cancer (TNBC), meaning the cancer tests negative for HER2 and has very low levels of hormone receptors (ER and PgR)
• People with TNBC who previously received at least 6 cycles of standard pre-surgery chemotherapy that included the immunotherapy drug pembrolizumab, plus chemotherapy drugs from the anthracycline and/or taxane families (with or without carboplatin)
• People who have had complete surgical removal of the breast tumour(s) and any affected lymph nodes
• People whose surgery results showed that cancer cells were still present after pre-surgery treatment (meaning the treatment did not achieve a complete response, classified as RCB Class I, II, or III)
• People for whom a stored tumour tissue sample from surgery is available along with its laboratory report
• People who are generally well enough to carry out light activity and care for themselves (ECOG Performance Status less than 2)
• People whose blood tests show their organs and bone marrow are functioning adequately (tests must be done within 28 days before joining)
• People whose side effects from previous treatments have mostly resolved to a mild level (Grade 1 or lower), with the exception of hair loss and certain hormone-related immune side effects that are stable and managed with hormone replacement
• People whose surgery wound has healed and at least 2 weeks (but no more than 10 weeks) have passed since surgery, and at least 3 weeks have passed since the last dose of pembrolizumab
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting treatment
• Women who could become pregnant, and male participants, must agree to use at least one effective form of contraception from the negative pregnancy test until 6 months after the last dose of study treatment
• People who are willing and able to attend all required study visits and follow procedures as set out in the study plan
• People who are enrolled in a social security or equivalent health coverage system

Standard of Care External Cohort (observation group):

• People who have been informed about the study and have not objected to their data being collected
• People aged 18 or older
• People with a confirmed laboratory diagnosis of TNBC, meaning the cancer tests negative for HER2 and has very low levels of hormone receptors (ER and PgR)
• People with TNBC who previously received at least 6 cycles of standard pre-surgery chemotherapy that included pembrolizumab plus anthracycline and/or taxane chemotherapy (with or without carboplatin)
• People who have had complete surgical removal of the breast tumour(s) and any affected lymph nodes
• People whose surgery results showed cancer cells were still present after pre-surgery treatment (RCB Class I, II, or III)
• People who have received at least one dose of pembrolizumab as a post-surgery treatment (given alongside or after radiotherapy)

Who may not be able to join:

Experimental Arm:

• People whose scans or physical examination show signs that the cancer has spread to other parts of the body (metastatic disease)
• People who received the chemotherapy drug capecitabine, or any immunotherapy drug other than pembrolizumab, as part of their pre-surgery treatment
• People with a known current or recent second cancer, unless it is a common type of skin cancer, early-stage cervical cancer, or a previously treated cancer with no signs of return for 2 or more years
• People for whom continuing pembrolizumab is medically unsuitable, including those with a known allergy or hypersensitivity to it (confirm with trial site)
• People who had a serious immune-related side effect from pembrolizumab that caused them to permanently stop taking it
• People for whom capecitabine treatment is medically unsuitable based on official prescribing guidelines (confirm with trial site)
• People with a complete deficiency of an enzyme called DPD (Dihydropyrimidine Dehydrogenase), which affects how the body processes certain chemotherapy drugs — screening for this deficiency is required
• People with an active infection at the time of enrolment
• People with a history of uncontrolled or symptomatic heart disease
• People who have taken the antiviral medication brivudine within the 4 weeks before joining the trial
• People who would need to use other experimental cancer treatments or additional chemotherapy, immunotherapy, or biologic cancer therapies not specified in the study protocol
• Women who are pregnant or currently breastfeeding
• People who are unable or unwilling to attend the required medical follow-up visits for geographic, family, social, or psychological reasons
• People who are in custody or under a legal guardianship or protective order
• People who have participated in another treatment trial within the 30 days before joining

Standard of Care External Cohort:

• People whose scans or physical examination after surgery show signs that the cancer has spread to other parts of the body
• People who received capecitabine or any immunotherapy drug other than pembrolizumab as part of their pre-surgery treatment
• People with a known current or recent second cancer, unless it is a common type of skin cancer, early-stage cervical cancer, or a previously treated cancer with no signs of return for 2 or more years
• People receiving any experimental cancer treatment other than pembrolizumab alone as post-surgery treatment

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