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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-arm, phase II study of 32 evaluable patients treated with NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy for hormone receptor positive (HR+), [i.e. Estrogen Receptor positive (ER+) and/or Progesterone Receptor positive (PR+)] HER2+ localized, non-metastatic stage I - IIb breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Midwestern Regional Medical Center
• Treatments: Anastrozole; Aromatase Inhibitors; Exemestane; Letrozole; Leuprolide; Pertuzumab; Trastuzumab

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