Phase 3 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 between 18 and 70 years old.
• People whose breast cancer has been staged as T2 through T4d, or T1c with cancer that has spread to the lymph nodes under the arm.
• People who have had their breast cancer confirmed by a tissue sample (biopsy) to be HER2-positive, meaning lab tests showed strong HER2 protein levels (IHC 3+) or confirmed by a gene test (FISH).
• People whose tumour can be measured by ultrasound or MRI scan, with the scan done within 1 month before joining the trial.
• People whose blood test results within 1 month before starting chemotherapy show the kidneys, liver, and bone marrow are working well enough for chemotherapy to be considered safe (confirm with trial site for specific values).
• People whose heart is pumping at 55% or more of its capacity, as measured by a heart ultrasound (echocardiogram).
• Women who could become pregnant must have a negative blood pregnancy test within 14 days before joining the trial.
• People who are in generally good physical condition and are fully active or have only minor limitations in daily activities (rated 0 or 1 on a standard medical scale).
• People who have read, understood, and signed a written consent form agreeing to take part.

Who may not be able to join:

• People whose breast cancer has spread to other parts of the body (Stage IV / metastatic disease).
• People who have cancer in both breasts at the same time.
• People who have already received any systemic treatment or radiotherapy for their current breast cancer, including chemotherapy, hormone therapy, or targeted therapy.
• People who have had a second, separate cancer diagnosis, unless it was a type of skin cancer that was fully treated (not melanoma) or an early-stage cervical condition that was fully treated.
• People who had major surgery unrelated to their breast cancer within 4 weeks before enrolling, or who have not fully recovered from a previous major surgery.
• People with significant heart problems, including any of the following:
  • A history of heart failure or poor heart pumping function.
  • Serious or uncontrolled abnormal heart rhythms, including a resting heart rate above 100 beats per minute or certain types of heart conduction problems.
  • Chest pain (angina) that requires ongoing medication to manage.
  • A significant heart valve problem.
  • Evidence of a previous full-thickness heart attack shown on a heart tracing (ECG).
  • Poorly controlled high blood pressure (above 180/100 mmHg).
• People with any other serious or uncontrolled medical condition that the trial doctor considers would make chemotherapy unsafe.
• People with a known allergy to any ingredient in the trial drugs, a known history of immune deficiency conditions (including HIV), other immune system disorders, or a history of organ transplant.

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