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 aged 18 or older, of any gender, who are able to understand and sign a consent form before any study-related procedures begin.
• People with breast cancer that has spread to other parts of the body or cannot be surgically removed.
• People whose tumours have always tested negative for HER2 protein (specifically "HER2 IHC 0") in every biopsy taken, and have never previously tested HER2-positive or HER2-low.
• People whose tumours can be either hormone receptor-positive or hormone receptor-negative.
• People with hormone receptor-positive breast cancer whose disease has gotten worse on, or who could not tolerate, treatment with CDK 4/6 inhibitor medicines plus hormone therapy.
• People with hormone receptor-negative breast cancer who have received at least one round of treatment for advanced or metastatic disease.
• People who have never previously been treated with any anti-HER2 therapy of any kind (including trastuzumab deruxtecan or similar medicines).
• People whose disease has progressed or worsened during or after their most recent treatment, or who could not tolerate it.
• People who have a suitable tumour tissue sample available (taken within the last 3 years) for testing, or who are able to have a new biopsy taken if no adequate sample exists.
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
• People who are reasonably physically functional (confirm with trial site regarding the specific performance score scale used).
• People whose heart is pumping at 50% or better capacity, confirmed by a heart scan taken within 28 days before starting treatment.
• People whose blood counts, kidney function, liver function, and blood clotting results all fall within acceptable ranges as confirmed by recent blood tests taken within 28 days before starting treatment.
• People who have waited a sufficient amount of time after previous treatments before entering the trial (the required waiting periods vary depending on the type of treatment previously received — confirm exact timeframes with trial site).
• Women who are past menopause or who have a negative pregnancy blood test; women who could become pregnant must use at least one highly effective form of contraception from the time of screening until 7 months after the last dose of the study drug.
• Male participants who are not surgically sterilised and are sexually active with a female partner who could become pregnant must use a condom from screening until 4 months after the last dose of the study drug.
• Female participants must not donate or retrieve eggs for their own use from the time of enrolment until at least 7 months after the last dose of the study drug.

Who may not be able to join:

• People with serious or uncontrolled heart problems, including a heart attack in the past 6 months, significant heart failure symptoms, or abnormal heart rhythm readings on an ECG.
• People with serious lung conditions, including a history of lung inflammation (ILD/pneumonitis) that required steroid treatment, current lung inflammation, or suspected lung inflammation that cannot be ruled out on scans.
• People with significant underlying lung diseases such as severe asthma, severe chronic obstructive pulmonary disease, or uncontrolled fluid around the lungs.
• People with autoimmune or inflammatory conditions where there is known or suspected involvement of the lungs.
• People who have had a complete removal of one lung (pneumonectomy).
• People with active or untreated cancer that has spread to the brain and is causing symptoms, or requires steroid medicines to manage symptoms (people with treated, stable, and symptom-free brain metastases that no longer need steroids may still be considered — confirm with trial site).
• People with a history of another cancer diagnosis, unless it was fully treated at least 5 years ago with no known remaining disease and low risk of return, or was a low-risk skin cancer or non-invasive cancer that has been fully treated.
• People who have had a severe allergic reaction to any of the medicines or ingredients used in this trial, or to any antibody-based treatments.
• People with an active uncontrolled infection that currently requires intravenous antibiotic, antiviral, or antifungal medicines.
• People with HIV that is not controlled, or with an active hepatitis B or C infection.
• People with substance use issues, significant medical conditions, or personal or social circumstances that the treating doctor believes would put them at risk or interfere with the study.
• People who still have unresolved side effects from previous cancer treatments that are above a mild level (hair loss is an exception; some ongoing mild side effects may be considered on a case-by-case basis by the treating doctor).
• People who are pregnant, breastfeeding, or planning to become pregnant.
• People who have received a live, weakened vaccine within 30 days before starting the study drug.
• People considered unsuitable for the trial for any other reason, as judged by the treating doctor.

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