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Keep this study
Lead
Western Regional Medical Center
Hormonal therapy with fulvestrant 500 mg to be administered before surgery With docetaxel, Trastuzumab, and pertuzumab to determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive patients with breast cancer.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic ER-positive (defined as ≥30% of positive cells) and HER2-positive (defined as overexpression by immunohistochemistry (3+) or 2+ and positive by defined by fluorescence or dual in situ hybridization.) breast cancer with minimal tumor size over 2 cm (≥T2 lesion) to receive neoadjuvant chemotherapy recommended by the treating physician
2. Eastern Cooperative Oncology Group (ECOG) performance status score \< 1
4. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 1.5 X ULN (≤ 3 mg/dL if clinically diagnosed with Gilbert syndrome) AST/ALT ≤ 2.5 X ULN (AST/ALT ≤ 5X ULN if clinically diagnosed with Gilbert syndrome)
5. Women of child-bearing potential (i.e., women who are pre-menoposaul or not surgically sterile) must have a negative serum pregnancy test within 2 weeks prior to beginning treatment
You may not be if
1. Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias
2. LVEF (left ventricular ejection fraction) \< 50% on any prior assessment. Note: Assessment of LVEF is done before and after trastuzumab-based chemotherapy as standard of care
3. Pregnant or lactating females
4. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
5. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
