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

NCT02689921 | Unknown Phase 2

• 2 other identifiers: MZ2016006ML30001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Evidence of Pathological Response

  The presence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. Pathological complete response (pCR) is defined as the absence of residual invasive cancer.

  One year

Secondary Outcomes (4)

• Duration of Treatment

  One year

• Evidence of Radiographic Response

  Assessed every 12 weeks up to one year

• Measurement of Left Ventricular Ejection Fraction (LVEF)

  Assessed every 12 weeks up to one year

• Mammaprint Genomic Analysis

  One year or up to 3 months after definitive surgery

Study Arms (1)

Neoadjuvant Biological Therapy

EXPERIMENTAL

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)

Drug: Exemestane; Drug: Letrozole; Drug: Anastrozole; Drug: Leuprolide Acetate; Drug: Pertuzumab; Drug: Trastuzumab

Interventions

Exemestane DRUG

Aromatase inhibitor

Also known as: Aromasin

Neoadjuvant Biological Therapy

Letrozole DRUG

Aromatase inhibitor

Also known as: Femara

Neoadjuvant Biological Therapy

Anastrozole DRUG

Aromatase inhibitor

Also known as: Arimidex

Neoadjuvant Biological Therapy

Leuprolide Acetate DRUG

Luteinizing Hormone-Releasing Hormone agonist

Also known as: Lupron, Lupron Depot

Neoadjuvant Biological Therapy

Pertuzumab DRUG

Monoclonal antibody (HER2/neu receptor antagonist)

Also known as: Perjeta

Neoadjuvant Biological Therapy

Trastuzumab DRUG

Monoclonal antibody (HER2/neu receptor antagonist)

Also known as: Herceptin

Neoadjuvant Biological Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Midwestern Regional Medical Center: lead

Study Sites (2)

Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

Location

Cancer Treatment Centers of America at Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Letrozole; Anastrozole; Leuprolide; pertuzumab; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Eugene Ahn, MD

  Midwestern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 24, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

US (2)