NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer (NEOADAPT)
Breast Neoplasms
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
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
Sites / Locations
- Southeastern Regional Medical Center
- Cancer Treatment Centers of America at Midwestern Regional Medical Center
Arms of the Study
Arm 1
Experimental
Neoadjuvant Biological Therapy
Subjects will receive an aromatase inhibitor for the duration of the study [exemestane (tablet, oral, 25 mg/day), letrozole (tablet, oral, 2.5 mg/day) or anastrozole (tablet, oral, 1 mg/day)]. Premenopausal subjects will receive leuprolide acetate (11.25 mg, intramuscular injection, 3-month intervals). Pertuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 840 mg, infused over 60-90 minutes; subsequent cycles: 420 mg, infused over 30-60 minutes). Trastuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 8 mg/kg, infused over 60-90 minutes; subsequent cycles: 6 mg/kg, infused over 30-60 minutes)