Study on Elacestrant with Trastuzumab and Pertuzumab for Advanced Triple Positive Breast Cancer

Inclusion Criteria

• Women aged 18 years or older.
• Able to provide informed consent.
• Diagnosed with triple-positive breast cancer (ER+, PR+, HER2+), meaning the cancer cells have certain hormone receptors and proteins.
• Cancer has progressed after at least one recommended prior therapy.
• Good overall health with a performance status score of 2 or less.
• Adequate organ function, including:
  • Hemoglobin level of at least 9.0 g/dL without recent transfusions.
  • Neutrophil count of at least 1.5×10^3/μL, or 1.0×10^3/μL for certain ethnic groups.
  • Platelet count of at least 100×10^3/μL.
  • Heart function with a baseline LVEF of 50% or higher.
• Not pregnant or breastfeeding and willing to use effective contraception during and after the study.
• Negative pregnancy test before starting the study.
• Use of highly effective contraception methods, such as IUD, tubal occlusion, vasectomy, or abstinence, during the study and for 7 months after the last dose.

Exclusion Criteria

• Previous treatment with a drug similar to elacestrant.
• More than two prior chemotherapy treatments for metastatic cancer.
• Untreated or active cancer spread to the brain.
• History of other cancers in the past 5 years, except for certain skin or cervical cancers.
• Difficulty taking oral medications or conditions affecting drug absorption.
• Known intolerance to elacestrant or its ingredients.
• Uncontrolled infections or illnesses.
  • Patients with hepatitis B or C must have undetectable viral loads.
  • HIV-positive patients are allowed if their viral load is undetectable.
• Taking medications that are not allowed in the study.
• Male participants are not included due to differences in male breast cancer.