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:

• Women aged 18 to 70 years who have been diagnosed with invasive breast cancer confirmed by a tissue biopsy, and who have not yet received any cancer treatment for breast cancer.
• People whose breast cancer has tested strongly positive for the HER2 protein, confirmed by a laboratory test (either an IHC score of 3+, or an IHC score of 2+ with a positive follow-up gene test).
• People whose breast cancer is classified as Stage II or Stage III (meaning the cancer has not spread to distant parts of the body, but may have spread to nearby lymph nodes).
• People who have at least one tumour that can be measured using standard imaging methods.
• People who are in generally good physical condition and able to carry out everyday activities, as measured by a standard health scoring tool (ECOG score of 0 or 1).
• People whose blood counts, liver function, kidney function, and heart function all meet specific healthy levels, confirmed by recent tests (without needing blood transfusions or certain medications to boost blood counts in the two weeks before screening).
• People whose heart pumping function (LVEF) is at or above 55%, confirmed by an ultrasound of the heart.
• People whose heart electrical activity shows a specific measurement (QTcF) below 470 milliseconds on an ECG test.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, must not be breastfeeding, and must agree to use reliable barrier contraception during the trial and for 6 months after treatment ends.
• People who are willing to take part voluntarily, sign a consent form, and commit to attending all required visits and study procedures.

Who may not be able to join:

• People with Stage IV breast cancer, meaning cancer that has spread to distant parts of the body.
• People diagnosed with inflammatory breast cancer.
• People who have previously received cancer treatment or radiotherapy for any type of cancer, or who currently have another active cancer (except for certain previously cured skin or cervical conditions).
• People who are currently enrolled in another clinical trial that involves any form of cancer treatment.
• People who have had major surgery unrelated to breast cancer within 4 weeks before the trial start date, or who have not fully recovered from such surgery.
• People with serious heart conditions, including a history of heart failure, uncontrolled irregular heartbeats, chest pain requiring medication, significant heart valve problems, evidence of a past heart attack on an ECG, or blood pressure that remains very high despite medication.
• People with an active infection that is not under control, a history of a weakened immune system, HIV, other immune deficiency conditions, or a history of organ transplant.
• People with a known allergy to any ingredient in the study drugs.
• Women who are pregnant, breastfeeding, have a positive pregnancy test at the start of the trial, or are unwilling to use effective contraception during the trial and for 6 months after the last dose.
• People with known or suspected interstitial lung disease, or certain other serious lung conditions that have occurred in the 3 months before joining, including conditions such as pulmonary fibrosis, pulmonary embolism, severe asthma, severe COPD, or lung-related autoimmune diseases; or people who have had a whole lung removed.
• People with other serious health conditions that could interfere with the treatment plan, or anyone the trial doctor considers unsuitable for the study for any other reason.

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