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 who have voluntarily agreed to take part and have signed a written consent form
• People aged 18 years or older
• People with locally advanced (inoperable) or metastatic breast cancer confirmed by tissue testing, where lab results show the cancer is "triple negative" — meaning it tests negative for ER, PR, and HER-2 receptors
• People who have at least one tumour that can be measured using standard imaging criteria
• Cohort 1: People with triple negative breast cancer that has not yet been treated for the advanced or metastatic stage — previous early-stage (neoadjuvant or adjuvant) treatment is allowed, provided the cancer did not return or spread until at least 12 months after that treatment ended
• Cohort 2: People with advanced or metastatic triple negative breast cancer whose cancer has not responded to at least one previous treatment
• People who are able to provide a tumour tissue sample (either a new biopsy or a stored tissue sample taken within the past 24 months) for laboratory testing
• People whose blood counts, liver function, kidney function, and other organ-related test results meet specific healthy ranges within 14 days before starting treatment (confirm with trial site)
• People with an expected survival of at least 3 months
• People with a general health/activity score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity
• People of childbearing potential who agree to use medically approved contraception during treatment and for 6 months after treatment ends; women of childbearing potential must also have a negative pregnancy blood test within 72 hours before enrolling

Who may not be able to join:

• People who have previously been treated with PD-1 or PD-L1 immunotherapy drugs; also, people in Cohort 1 who have previously received albumin-bound paclitaxel (nab-paclitaxel)
• People with a known allergy to any of the drugs used in this trial
• People who have had allergic reactions to vitamin A-related medications
• People with a history of active autoimmune disease that required ongoing systemic treatment in the past 2 years (certain low-dose steroid exceptions may apply — confirm with trial site)
• People diagnosed with an immune deficiency condition, or who have been on systemic steroids or other immune-suppressing treatments in the 7 days before enrolling (certain low-dose exceptions may apply — confirm with trial site)
• People who have had another active or progressing cancer in the past 5 years, except for certain localised cancers that have been fully treated and cured, such as some skin cancers or early-stage cervical cancer
• People with known active cancer spread to the brain or central nervous system
• People with a history of non-infectious lung inflammation that required steroid treatment
• People with an active infection currently requiring treatment
• People with serious, uncontrolled high blood pressure, diabetes, or high cholesterol/lipid levels
• People with a history of moderate-to-severe heart failure (Class II–IV) or a heart attack within the 6 months before enrolling
• People who test positive for HIV during the screening process
• People with active hepatitis B or hepatitis C, based on specific blood test results (confirm with trial site)
• People with other serious ongoing physical or mental health conditions
• People currently taking any medications that are not permitted to be used alongside the trial drugs, unless those medications have been stopped at least 7 days before enrolling
• Women who are currently breastfeeding
• People who have participated in another clinical trial of an anti-cancer drug within the past 4 weeks
• People who are unable to swallow, have a bowel obstruction, or have any other condition that would affect how medication is taken or absorbed
• People whom the trial investigators consider unsuitable for any other reason

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