Phase 2 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 been diagnosed with metastatic triple-negative breast cancer (TNBC) confirmed by a tissue sample, or who are strongly suspected of having it while awaiting confirmation.
• People whose breast cancer tumor tests show very low or no estrogen receptor (ER) and progesterone receptor (PR) activity, based on specific laboratory scoring.
• People whose tumor tests negative for HER2, confirmed by standard laboratory methods.
• People whose tumor tests negative for a protein called PD-L1, confirmed by an approved laboratory.
• People who have measurable or detectable disease that can be tracked during the trial.
• People who are willing to have a tissue biopsy, or who already have enough stored tumor tissue available that meets specific requirements (confirm with trial site for details on tissue type and quantity).
• People who have not previously received treatment for metastatic TNBC. Those who received taxane-based chemotherapy as earlier treatment must have had at least 12 months free of disease after finishing that treatment.
• People aged 18 years or older.
• People who are in reasonably good general health, able to carry out light activity and care for themselves (as measured by standard medical scoring tools).
• People who weigh more than 30 kg.
• People who are expected to live for at least 12 weeks.
• People whose blood test results show adequate levels of white blood cells, platelets, and hemoglobin (confirm with trial site for specific values).
• People whose blood test results show that the liver and kidneys are functioning adequately (confirm with trial site for specific values).
• Women who are post-menopausal, or women who are pre-menopausal and have a negative pregnancy test before joining the trial.
• Women who are able to become pregnant and agree to use reliable contraception during the trial and for 180 days after finishing treatment.
• People living with HIV, provided they have no detectable virus in their blood, have a CD4 immune cell count above 250, and are on a stable HIV treatment regimen.
• People who are willing and able to follow the trial schedule, attend appointments, and complete all required visits and follow-up.
• People who are able to understand and sign a consent form, or who have a caregiver or legal guardian who can provide consent on their behalf if needed.

Who may not be able to join:

• People who are not considered suitable candidates for a chemotherapy combination of carboplatin and gemcitabine as a first treatment for their metastatic TNBC.
• People who have received chemotherapy, radiation to a large portion of the bone marrow, or other cancer-directed biological treatments within the past 30 days (or 42 days for certain specific chemotherapy drugs).
• People who have previously received immunotherapy for metastatic disease.
• People who are still experiencing significant side effects (grade 2 or higher) from previous cancer treatments, with some exceptions such as hair loss or mild skin changes.
• People with significant hormone-related side effects from prior treatment (such as thyroid, adrenal, or blood sugar problems) unless those conditions have been stable on a steady treatment dose for at least 2 weeks.
• People who are currently participating in another clinical trial or who have received an experimental treatment within the past 30 days.
• People who have received a live vaccine within the 6 months before joining, or within 30 days of starting the trial drugs.
• People who have had major surgery within 28 days before starting the trial drugs.
• People who have been taking immune-suppressing medications within 14 days before starting the trial drugs, with some specific exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions (confirm with trial site for details).
• People with active cancer that has spread to the brain or spinal cord, or cancer affecting the membranes surrounding the brain, unless prior treatment for brain metastases has been completed at least 4 weeks before joining and specific recovery criteria are met.
• People with a known allergy or serious reaction to drugs similar to the trial drugs, or a history of serious reactions to vaccines such as severe allergic reactions or breathing difficulties.
• People with a specific type of irregular heart rhythm detected on an electrical heart test (ECG) showing a measurement called QTcF of 470 ms or more.
• People with serious uncontrolled medical conditions such as active infections, heart failure, uncontrolled high blood pressure, unstable heart disease, irregular heart rhythm, lung disease, serious digestive conditions with ongoing diarrhoea, or significant mental health conditions that may affect the ability to participate.
• People who are pregnant or breastfeeding.
• People who have an active autoimmune disease that has required systemic medical treatment within the past 2 years. Hormone or supplement replacement therapies (such as thyroid hormone or insulin) are not considered systemic treatment for this purpose.
• People with a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease).
• People with a history of a primary immune system deficiency condition.
• People with active tuberculosis, active hepatitis B, or active hepatitis C infection. People with past resolved hepatitis B or hepatitis C infections that are no longer detectable may still be eligible (confirm with trial site).
• People with a history of other cancers, unless they have completed treatment with curative intent, have been considered disease-free for at least 1 year, and meet additional criteria set by the trial (certain minor skin cancers and cervical pre-cancers are exceptions).
• People who are unlikely to be able to follow the trial schedule, for example due to living very far from the treatment centre.
• People who have previously received an organ transplant from another person.

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