Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

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.

Inclusion Criteria:

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

3. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5
g/dL

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

Exclusion Criteria:

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