NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

Inclusion Criteria:

- Ability to provide signed, written informed consent

- Histologically or cytologically confirmed non-metastatic adenocarcinoma of the breast
(stage I-II)

- Candidate for curative-intent treatment

- ER+ and/or PR+ and HER2-positive (Fluorescence In Situ Hybridization-positive or 3+ by
Immunohistochemistry staining)

- Life expectancy greater than 5 years

- Left Ventricular Ejection Fraction > 50% at baseline (within 30 days of day 0)

- Eastern Cooperative Oncology Group performance status ≤2

- Absolute Neutrophil Count >1000/µL

- Platelets ≥50,000/µL

- Hemoglobin >8.0 g/dL,

- Creatinine ≤3.0 x upper limit of normal (ULN)

- Bilirubin ≤3.0 x ULN

- Aspartate aminotransferase or Alanine aminotransferase <5.0 x ULN

- Negative serum pregnancy test for women <12 months after the onset of menopause unless
surgically sterilized

- Agreement by women of childbearing potential and male participants with partners of
childbearing potential to use a "highly effective", non-hormonal form of contraception
or two "effective" forms of non-hormonal contraception by the patient and/or partner.

Exclusion Criteria:

- Active infection

- Presence of known metastases (stage IV disease)

- Pregnant or lactating women

- Prior chemotherapy or radiation therapy for the primary breast cancer

- Concomitant malignancies or previous malignancies within the last 5 years except
adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ
of the cervix.

- History of significant cardiac disease, cardiac risk factors or uncontrolled
arrhythmias

- Current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary or metabolic disease including diabetes, wound healing
disorders, ulcers or bone fractures)

- Major surgical procedure or significant traumatic injury within 28 days prior to study
treatment start or anticipated need for major surgery during the course of study
treatment

- Current known infection with Human Immunodeficiency Virus (HIV), Hepatitis B virus
(HBV) or Hepatitis C Virus (HCV)

- Receipt of intravenous antibiotics for infection within 14 days prior to receiving
study treatment

- Current chronic daily treatment with corticosteroids (dose >10 mg/day
methylprednisolone equivalent) except inhaled steroids

- Known hypersensitivity to any of the study drugs

- Assessment by the investigator to be unable or unwilling to comply with the
requirements of the protocol