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

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ClinicalTrials.gov Identifier: NCT02689921
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Eugene Ahn, Midwestern Regional Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Exemestane Drug: Letrozole Drug: Anastrozole Drug: Leuprolide Acetate Drug: Pertuzumab Drug: Trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT)
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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)

Drug: Exemestane
Aromatase inhibitor
Other Name: Aromasin

Drug: Letrozole
Aromatase inhibitor
Other Name: Femara

Drug: Anastrozole
Aromatase inhibitor
Other Name: Arimidex

Drug: Leuprolide Acetate
Luteinizing Hormone-Releasing Hormone agonist
Other Names:
  • Lupron
  • Lupron Depot

Drug: Pertuzumab
Monoclonal antibody (HER2/neu receptor antagonist)
Other Name: Perjeta

Drug: Trastuzumab
Monoclonal antibody (HER2/neu receptor antagonist)
Other Name: Herceptin




Primary Outcome Measures :
  1. Evidence of Pathological Response [ Time Frame: One year ]
    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.


Secondary Outcome Measures :
  1. Duration of Treatment [ Time Frame: One year ]
    Median number of days between Day 0 (first treatment of trastuzumab and pertuzumab) and three weeks after the last dose of neoadjuvant trastuzumab and pertuzumab on treatment protocol.

  2. Evidence of Radiographic Response [ Time Frame: Assessed every 12 weeks up to one year ]
    Change in dimensions (millimeters) of target lesions (along long axis) and non-target lesions (along long axis for non-lymphatic lesions and short axis for lymph nodes) as observed by Magnetic Resonance Imaging and quantified by modified RECIST 1.1 criteria.

  3. Measurement of Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Assessed every 12 weeks up to one year ]
    Determination of cardiac function as measured by echocardiogram or multi-gated acquisition scan (MUGA).

  4. Mammaprint Genomic Analysis [ Time Frame: One year or up to 3 months after definitive surgery ]
    Mammaprint will estimate the risk level of the subject's tumor.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689921


Locations
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United States, Georgia
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
United States, Illinois
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
Sponsors and Collaborators
Midwestern Regional Medical Center
Investigators
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Principal Investigator: Eugene Ahn, MD Midwestern Regional Medical Center
  Study Documents (Full-Text)

Documents provided by Eugene Ahn, Midwestern Regional Medical Center:

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Responsible Party: Eugene Ahn, Principal Investigator, Midwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT02689921     History of Changes
Other Study ID Numbers: MZ2016006
ML30001 ( Other Identifier: Genentech, Inc. )
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pertuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Letrozole
Anastrozole
Exemestane
Leuprolide
Aromatase Inhibitors
Antineoplastic Agents, Immunological
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents