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

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

Sponsors

Lead sponsor: Midwestern Regional Medical Center

Source 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.

Overall Status Active, not recruiting
Start Date April 2016
Completion Date December 2018
Primary Completion Date December 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Evidence of Pathological Response One year
Secondary Outcome
Measure Time Frame
Duration of Treatment One year
Evidence of Radiographic Response Assessed every 12 weeks up to one year
Measurement of Left Ventricular Ejection Fraction (LVEF) Assessed every 12 weeks up to one year
Mammaprint Genomic Analysis One year or up to 3 months after definitive surgery
Enrollment 7
Condition
Intervention

Intervention type: Drug

Intervention name: Exemestane

Description: Aromatase inhibitor

Arm group label: Neoadjuvant Biological Therapy

Other name: Aromasin

Intervention type: Drug

Intervention name: Letrozole

Description: Aromatase inhibitor

Arm group label: Neoadjuvant Biological Therapy

Other name: Femara

Intervention type: Drug

Intervention name: Anastrozole

Description: Aromatase inhibitor

Arm group label: Neoadjuvant Biological Therapy

Other name: Arimidex

Intervention type: Drug

Intervention name: Leuprolide Acetate

Description: Luteinizing Hormone-Releasing Hormone agonist

Arm group label: Neoadjuvant Biological Therapy

Intervention type: Drug

Intervention name: Pertuzumab

Description: Monoclonal antibody (HER2/neu receptor antagonist)

Arm group label: Neoadjuvant Biological Therapy

Other name: Perjeta

Intervention type: Drug

Intervention name: Trastuzumab

Description: Monoclonal antibody (HER2/neu receptor antagonist)

Arm group label: Neoadjuvant Biological Therapy

Other name: 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Eugene Ahn, MD Principal Investigator Midwestern Regional Medical Center
Location
facility
Southeastern Regional Medical Center | Newnan, Georgia, 30265, United States
Cancer Treatment Centers of America at Midwestern Regional Medical Center | Zion, Illinois, 60099, United States
Location Countries

United States

Verification Date

September 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Eugene Ahn

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Neoadjuvant Biological Therapy

Arm group type: Experimental

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)

Acronym NEOADAPT
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov