A Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer (NeoTHERa)
University of Kansas Medical Center
Summary
This is a randomized phase II study to evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin/Perjeta and Docetaxel+Herceptin/Perjeta) in HER2 amplified/positive early breast cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * 18 years of age or older * Histologically confirmed cT2-T3 N0-N2, cT1 N1-N2, or cTX N1-N2 HER2 positive breast cancer (The invasive tumor must be HER2-positive based on the current ASCO-CAP guidelines; Patients are eligible regardless of estrogen receptor (ER) or progesterone receptor (PR) expression status. However, percentage of both ER and PR positivity must be documented in the pathology report.) * No prev…
Interventions
- DrugCarboplatin
All of the treatment being received by the study participants during the course of the study is standard of care.
- DrugDocetaxel
All of the treatment being received by the study participants during the course of the study is standard of care.
- DrugTrastuzumab (or biosimilar)
All of the treatment being received by the study participants during the course of the study is standard of care.
- DrugPertuzumab (or biosimilar)
All of the treatment being received by the study participants during the course of the study is standard of care.
Locations (8)
- The University of Kansas Cancer Center (KUCC)Fairway, Kansas
- The University of Kansas Cancer Center - WestwoodKansas City, Kansas
- KUCC - Indian CreekOverland Park, Kansas
- KUCC - Overland ParkOverland Park, Kansas
- KUCC - BriarcliffWestwood, Kansas
- KUCC - OlatheWestwood, Kansas