Clinical trial NCT02689921: NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer
Official title: A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evidence of Pathological Response
timeFrame: One year
Secondary outcomes:
measure: Duration of Treatment
timeFrame: One year
measure: Evidence of Radiographic Response
timeFrame: Assessed every 12 weeks up to one year
measure: Measurement of Left Ventricular Ejection Fraction (LVEF)
timeFrame: Assessed every 12 weeks up to one year
measure: Mammaprint Genomic Analysis
timeFrame: One year or up to 3 months after definitive surgery
Other outcomes:
Locations:
city: Newnan
country: United States
facility: Southeastern Regional Medical Center
state: Georgia
city: Zion
country: United States
facility: Cancer Treatment Centers of America at Midwestern Regional Medical Center
state: Illinois
Study officials:
affiliation: Midwestern Regional Medical Center
name: Eugene Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: