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 been diagnosed with breast cancer (confirmed by lab testing) that cannot be surgically removed or has spread, and whose cancer has tested negative for the HER2 protein using specific laboratory methods.
• People whose breast cancer has not been previously treated at stage II or III, with specific tumour and lymph node sizes depending on hormone receptor status (confirm with trial site for exact staging details).
• People whose cancer has not spread to other parts of the body, as confirmed by imaging or lab tests.
• People aged 19 years or older.
• People whose breast cancer tumour has been confirmed as "HER2-enriched" subtype through a specific genetic test called PAM50.
• People who have enough stored tumour tissue samples (15–20 FFPE slides) available for the PAM50 genetic test.
• People with a general health performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity.
• People whose blood counts are within acceptable ranges, including haemoglobin, white blood cells, and platelets.
• People whose kidneys are functioning well enough, based on blood or urine test results.
• People whose liver is functioning well enough, based on blood test results.
• People whose heart is functioning well enough, with a heart pumping function (ejection fraction) of at least 50%, confirmed by a heart scan.
• Women who could potentially become pregnant must have a negative pregnancy test taken within 72 hours before starting the trial treatment.

Who may not be able to join:

• People who have previously been treated for invasive breast cancer on either side.
• People whose breast cancer has already spread to distant parts of the body.
• People who have had another cancer diagnosis within the last 5 years, except for certain skin cancers that were fully treated, early-stage cervical cancer in situ, or thyroid cancer smaller than 2cm of specific types.
• People with inflammatory breast cancer (a specific aggressive type, classified as cT4d).
• People with cancer in both breasts at the same time (though cancer with multiple spots in the same breast may still be eligible — confirm with trial site).
• People with occult breast cancer (cancer found without a detectable tumour in the breast).
• People with a history of hepatitis B, hepatitis C, or HIV infection.
• Women who could potentially become pregnant and are not willing to use highly effective non-hormonal contraception during treatment (certain methods such as calendar-based or withdrawal methods are not considered acceptable).
• People with infections that are not under control, or other serious illnesses.
• People with uncontrolled high blood pressure or active heart or blood vessel conditions, including recent stroke, unstable chest pain, heart attack within the past 6 months, significant heart failure, or poorly controlled irregular heartbeat.
• People who, in the opinion of the trial investigators, have physical, psychological, geographic, or other conditions that would make it difficult to follow the trial requirements.
• People who have had a severe allergic reaction to any of the study drugs used in this trial (doxorubicin, cyclophosphamide, paclitaxel, docetaxel, or trastuzumab/Herzuma).
• People who already have moderate or severe nerve damage in their hands or feet (peripheral neuropathy graded 2 or higher on a standard medical scale).

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