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 hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body (metastatic).
• People whose cancer can be measured or tracked using standard imaging scans.
• People whose doctor considers them a suitable candidate for a chemotherapy medicine called capecitabine.
• People who have received no more than one prior chemotherapy treatment for their metastatic breast cancer.
• People who have previously been treated with a type of hormone therapy that includes a CDK4/6 inhibitor.
• People who are at least 18 years old.
• People who are generally well enough to carry out light activity or self-care (measured on a standard medical scale called ECOG, at levels 0, 1, or 2).
• People with a life expectancy of at least 12 weeks.
• People whose blood counts, liver function, kidney function, and calcium levels meet the specific healthy ranges required by the trial (confirm with trial site).
• People taking denosumab or zoledronic acid (bone-strengthening medicines) who have been on a stable dose for at least 6 months before joining, with a 3-week break before the first study dose.
• People who are willing and able to use adequate contraception during the trial and for a set period afterward — 6 months for women and 3 months for men — and who agree to immediately inform their treating doctor if pregnancy occurs or is suspected.
• People who are able to understand and sign a consent form approved by an ethics review board.
• People who have a stored tissue sample from a previous biopsy of their metastatic cancer available (those without a sample may still be considered with approval from the lead investigator).

Additional criteria for the Phase Ib part of the trial:

• People who are a candidate for capecitabine or are already taking it at a specific dose (1,000 mg/m² twice daily, 14 days on and 7 days off), with no more than mild side effects from that dose for at least one treatment cycle.

Additional criteria for the Phase II part of the trial:

• People whose bone metastases are getting worse based on recent imaging scans, or who are experiencing signs of clinical worsening such as increasing bone pain or rising tumour markers, as determined by their treating doctor.

Who may not be able to join:

• People who have recently received certain treatments before the trial start date, including: radiation therapy within the past 1 week; chemotherapy or antibody-drug treatments within the past 3 weeks; immunotherapy within the past 3 weeks; or oral chemotherapy or targeted therapy within 5 half-lives of that medicine.
• People currently taking certain medicines that strongly affect how other drugs are processed in the body, or medicines known to affect heart rhythm, within 5 half-lives of those medicines (confirm with trial site).
• People with brain metastases that have not yet been treated. People with previously treated brain metastases may still be considered, provided there is no sign of the cancer growing there and they are no longer taking steroid medicines for it.
• People with a known history of serious allergic reactions to medicines similar in composition to zunsemetinib or other medicines used in this trial.
• People with a history of untreated bone-related complications (such as fractures or spinal cord compression), or those expected to change their bone-protective medication after joining the study.
• People with serious uncontrolled health conditions, including active infection, severe heart failure, unstable chest pain, or irregular heart rhythm.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test within 14 days before the first study dose.
• People living with HIV whose immune cell counts are below a certain level (CD4+ T-cell count below 350 cells/mcL), or who have had a serious HIV-related infection in the past 12 months.
• People whose heart electrical activity measurement (QTcF interval) is above 470 milliseconds at the screening stage.

Additional exclusion criteria for the Phase Ib part of the trial:

• People who have taken capecitabine within 2 weeks before the first study dose (though people currently taking it may still be considered, as long as they pause dosing for 2 weeks beforehand).

Additional exclusion criteria for the Phase II part of the trial:

• People who have previously received capecitabine as a treatment for their metastatic breast cancer.
• People with a history of another cancer, unless all treatment for that cancer was completed and there was no sign of disease for at least 2 years before the trial start date.

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