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

Breast Neoplasms Clinical Trial

— NEOADAPT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02689921
• Other study ID #: MZ2016006
• Secondary ID: ML30001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2018
• Source: Midwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Exemestane
Aromatase inhibitor
• Letrozole
Aromatase inhibitor
• Anastrozole
Aromatase inhibitor
• Leuprolide Acetate
Luteinizing Hormone-Releasing Hormone agonist
• Pertuzumab
Monoclonal antibody (HER2/neu receptor antagonist)
• Trastuzumab
Monoclonal antibody (HER2/neu receptor antagonist)

Locations

Country	Name	City	State
United States	Southeastern Regional Medical Center	Newnan	Georgia
United States	Cancer Treatment Centers of America at Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	One year
Secondary	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.	Assessed every 12 weeks up to one year
Secondary	Measurement of Left Ventricular Ejection Fraction (LVEF)	Determination of cardiac function as measured by echocardiogram or multi-gated acquisition scan (MUGA).	Assessed every 12 weeks up to one year
Secondary	Mammaprint Genomic Analysis	Mammaprint will estimate the risk level of the subject's tumor.	One year or up to 3 months after definitive surgery