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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Southeastern Regional Medical Center
Newnan, Georgia, United States
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion, Illinois, United States
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.
Time frame: One year
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.
Time frame: One year
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.
Time frame: Assessed every 12 weeks up to one year
Measurement of Left Ventricular Ejection Fraction (LVEF)
Determination of cardiac function as measured by echocardiogram or multi-gated acquisition scan (MUGA).
Time frame: Assessed every 12 weeks up to one year
Mammaprint Genomic Analysis
Mammaprint will estimate the risk level of the subject's tumor.
Time frame: One year or up to 3 months after definitive surgery
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Luteinizing Hormone-Releasing Hormone agonist
Monoclonal antibody (HER2/neu receptor antagonist)
Monoclonal antibody (HER2/neu receptor antagonist)