HERizon-Breast: Personalized Treatment Study for Long-Term Remission in HER2+ Metastatic Breast Cancer

Inclusion Criteria

• Adults aged 18 or older with a confirmed diagnosis of advanced or metastatic breast cancer that cannot be surgically removed.
• Stage IV cancer at diagnosis.
• HER2 test results showing a score of 3+.
• Expected to live at least 12 more weeks.
• Must be fit for surgery or potentially operable if the cancer responds to initial treatment.
• Must have measurable cancer as per specific medical criteria.
• Must provide written consent to participate.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have adequate organ function based on specific lab tests.
• Women must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
• Men must agree to use contraception or be abstinent during the study and for at least 7 days after the last treatment.
• Participants with hepatitis B or C must meet specific criteria regarding viral load and treatment.
• Must meet specific blood and organ function criteria as outlined in the study.

Exclusion Criteria

• Patients with HER2+ breast cancer with certain test results not meeting study criteria.
• Previous treatment with anti-HER2 therapy or any systemic anti-cancer treatment for breast cancer.
• Participation in another study or use of an investigational device within 2 weeks before starting this study.
• Diagnosis of immunodeficiency or use of certain steroid therapies recently.
• Another progressing cancer or one treated within the last 3 years, except for certain skin cancers.
• Known cancer spread to the brain or spinal cord.
• History of lung diseases requiring steroids or current lung disease.
• Severe nerve damage.
• Active infection needing antibiotics.
• History of HIV infection.
• Difficulty swallowing pills.
• Any condition or treatment that might interfere with the study.
• Psychiatric or substance abuse issues affecting study participation.
• Pregnant or breastfeeding women, or those planning to conceive during the study.
• Previous organ transplant.
• Significant heart problems within the last year.
• Low heart function as per specific tests.
• Known intolerance to study drugs.
• Recent major surgery without adequate healing.