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

NCT ID: NCT02689921

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Exemestane

Intervention Type: DRUG

Aromatase inhibitor

Letrozole

Intervention Type: DRUG

Aromatase inhibitor

Anastrozole

Intervention Type: DRUG

Aromatase inhibitor

Leuprolide Acetate

Intervention Type: DRUG

Luteinizing Hormone-Releasing Hormone agonist

Pertuzumab

Intervention Type: DRUG

Monoclonal antibody (HER2/neu receptor antagonist)

Trastuzumab

Intervention Type: DRUG

Monoclonal antibody (HER2/neu receptor antagonist)

Interventions

Exemestane

Aromatase inhibitor

Intervention Type: DRUG

Letrozole

Aromatase inhibitor

Intervention Type: DRUG

Anastrozole

Aromatase inhibitor

Intervention Type: DRUG

Leuprolide Acetate

Luteinizing Hormone-Releasing Hormone agonist

Intervention Type: DRUG

Pertuzumab

Monoclonal antibody (HER2/neu receptor antagonist)

Intervention Type: DRUG

Trastuzumab

Monoclonal antibody (HER2/neu receptor antagonist)

Intervention Type: DRUG

Other Intervention Names

Aromasin; Femara; Arimidex; Lupron; Lupron Depot; Perjeta; Herceptin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Midwestern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eugene Ahn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugene Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Midwestern Regional Medical Center

Locations

Southeastern Regional Medical Center

Newnan, Georgia, United States

Cancer Treatment Centers of America at Midwestern Regional Medical Center

Zion, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ML30001

Identifier Type: OTHER

Identifier Source: secondary_id

MZ2016006

Identifier Type: -

Identifier Source: org_study_id