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

Primary Purpose

Breast Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Exemestane

Letrozole

Anastrozole

Leuprolide Acetate

Pertuzumab

Trastuzumab

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Neoadjuvant Biological Therapy

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of Treatment

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.

Evidence of Radiographic Response

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.

Measurement of Left Ventricular Ejection Fraction (LVEF)

Determination of cardiac function as measured by echocardiogram or multi-gated acquisition scan (MUGA).

Mammaprint Genomic Analysis

Mammaprint will estimate the risk level of the subject's tumor.

Full Information

NCT ID

NCT02689921

First Posted

February 4, 2016

Last Updated

September 27, 2018

Sponsor

Midwestern Regional Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02689921

Brief Title

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

Acronym

NEOADAPT

Official Title

A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Midwestern Regional Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant Biological Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Exemestane

Other Intervention Name(s)

Aromasin

Intervention Description

Aromatase inhibitor

Intervention Type

Drug

Intervention Name(s)

Letrozole

Other Intervention Name(s)

Femara

Intervention Description

Aromatase inhibitor

Intervention Type

Drug

Intervention Name(s)

Anastrozole

Other Intervention Name(s)

Arimidex

Intervention Description

Aromatase inhibitor

Intervention Type

Drug

Intervention Name(s)

Leuprolide Acetate

Other Intervention Name(s)

Lupron, Lupron Depot

Intervention Description

Luteinizing Hormone-Releasing Hormone agonist

Intervention Type

Drug

Intervention Name(s)

Pertuzumab

Other Intervention Name(s)

Perjeta

Intervention Description

Monoclonal antibody (HER2/neu receptor antagonist)

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin

Intervention Description

Monoclonal antibody (HER2/neu receptor antagonist)

Primary Outcome Measure Information:

Title

Evidence of Pathological Response

Description

Time Frame

One year

Secondary Outcome Measure Information:

Title

Duration of Treatment

Description

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.

Time Frame

One year

Title

Evidence of Radiographic Response

Description

Time Frame

Assessed every 12 weeks up to one year

Title

Measurement of Left Ventricular Ejection Fraction (LVEF)

Description

Determination of cardiac function as measured by echocardiogram or multi-gated acquisition scan (MUGA).

Time Frame

Assessed every 12 weeks up to one year

Title

Mammaprint Genomic Analysis

Description

Mammaprint will estimate the risk level of the subject's tumor.

Time Frame

One year or up to 3 months after definitive surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugene Ahn, MD

Organizational Affiliation

Midwestern Regional Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Southeastern Regional Medical Center

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Cancer Treatment Centers of America at Midwestern Regional Medical Center

City

Zion

State/Province

Illinois

ZIP/Postal Code

60099

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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