Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Midwestern Regional Medical Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer
