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 diagnosed with metastatic breast cancer that has a specific type of BRCA1 or BRCA2 gene change (called a "deleterious somatic mutation") detected through an approved blood test — not an inherited (germline) mutation.
• People with triple-negative breast cancer (a specific subtype where the cancer tests negative for certain receptors) whose cancer has continued to grow after at least one prior chemotherapy treatment for metastatic disease.
• People with hormone receptor-positive, HER2-negative breast cancer whose cancer has continued to grow after at least one prior hormone-based treatment for metastatic disease, or where hormone-based treatment is considered unsuitable.
• People who have measurable or evaluable signs of the disease that can be tracked during the trial.
• People who have received any number of prior treatments before joining.
• People who may have received up to one prior platinum-based chemotherapy, as long as the cancer did not progress during or within 6 months after finishing that treatment.
• People who are at least 2 weeks past their last cancer treatment and have recovered from most side effects (mild nerve-related side effects up to a certain level may still be acceptable — confirm with trial site).
• People who are at least 2 weeks past their last radiation therapy and have recovered from most side effects.
• People aged 18 or older at the time of signing the consent form.
• People with a general health status that meets a standard medical rating of 0, 1, or 2 on a scale used to measure ability to carry out daily activities (confirm with trial site).
• People whose blood and organ function tests (including blood cell counts, kidney function, and liver function) fall within acceptable ranges, tested within 10 days before starting treatment.
• People with a history of cancer spread to the brain, if that condition has been stable for at least one month after whole-brain radiation, or at least 2 weeks after targeted (stereotactic) radiation, or at least one month after surgery — and who are not currently needing steroid medications to manage it.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the study drug.
• Women who could become pregnant must use an acceptable method of contraception throughout the study and for 7 months after the last dose of the study drug.
• Male participants must use an adequate method of contraception from the first dose through 7 months after the last dose, and must not donate sperm during this time.
• People who are willing and able to provide written informed consent.

Who may not be able to join:

• People whose cancer has a BRCA1 or BRCA2 mutation that was inherited (germline mutation) rather than developed in the tumour (somatic mutation).
• People whose BRCA result only shows a "variant of unknown significance" or a non-harmful BRCA change, without a confirmed harmful somatic mutation.
• People who have previously been treated with a type of drug called a PARP inhibitor.
• People who received any chemotherapy, targeted therapy, or radiation within 2 weeks before the trial start date and have not yet recovered from related side effects (with some exceptions for mild nerve-related side effects).
• People who participated in another clinical trial involving an investigational drug within 4 weeks before starting this trial.
• People who have had major surgery and have not yet fully recovered.
• People with another cancer that is currently progressing or requires active treatment (certain skin cancers and early-stage cervical changes may be exceptions — confirm with trial site).
• People with known brain or spinal fluid involvement from their cancer that has not been treated.
• People with known HIV infection.
• People with known active Hepatitis B or Hepatitis C infection.
• People currently taking certain medications that strongly affect how drugs are processed by the body (known as strong P-glycoprotein inhibitors — confirm with trial site).
• People currently on any other cancer treatment, including chemotherapy, hormone therapy, immunotherapy, or another investigational therapy.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and for 7 months after the last dose.
• People with known psychiatric conditions or substance use disorders that may make it difficult to follow the trial requirements.
• People with any other medical condition, past treatment, or lab result that the treating doctor believes could affect the trial results or make participation unsafe.

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