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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
All of the treatment being received by the study participants during the course of the study is standard of care.
All of the treatment being received by the study participants during the course of the study is standard of care.
All of the treatment being received by the study participants during the course of the study is standard of care.
Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms
To evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin+Perjeta (TCHP) and Docetaxel+Herceptin+Perjeta (THP)) in HER2+ breast cancer.
Time frame: At time of breast surgery
Residual cancer burden (RCB)
Determine residual cancer burden (RCB) 0+1 rate
Time frame: At time of breast surgery
Assess the toxicity and tolerability of each regimen
Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Only grade 3 and higher CTCAE toxicities will be collected. Alopecia of any grade will not be collected.
Time frame: Start of study treatment (6 cycles every 21 days) until 30 days after last dose of study treatment.
HER2DX pathological complete response (pCR) score status
Assess pathological complete response (pCR) and residual cancer burden (RCB) by HER2DX pCR score status. The HER2DX test reports three pCR Likelihood Groups for response (High, Medium and Low).
Time frame: Results of HER2DX testing are expected to be available within 3-6 weeks of submission of FFPE samples
Recurrence-Free Survival (RFS)
RFS is defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause.
Time frame: From 3- and 5-years from diagnosis
Event-Free Survival (EFS)
EFS is defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant) or to breast cancer-related death.
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All of the treatment being received by the study participants during the course of the study is standard of care.
Time frame: From 3- and 5-years from diagnosis
Overall Survival (OS)
OS is defined as the time from diagnosis to death from any cause
Time frame: From 3- and 5-years from diagnosis