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Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy

Completed
Conditions
Breast Neoplasms
Interventions
Drug: NET or NCT
Registration Number
NCT05673850
Lead Sponsor
Peking University
Brief Summary

In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. However, the association between HER2-low status with response to endocrine therapy is largely unknown. In this study, we included 518 ER-positive BC patients who received either neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NCT). The pathologic complete response rate (pCR) of HER2-low and HER2-zero tumors re-sponding to neoadjuvant therapies were compared. The difference in disease-free survival (DFS) and overall survival (OS) between the two groups was also analyzed. The pCR (defined as ypT0/isNx) in HER2-low BCs and in HER2-zero BCs for NET cohort and NCT cohort were compared.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
518
Inclusion Criteria

patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021

Exclusion Criteria

none

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
NETNET or NCT-
NCTNET or NCT-
Primary Outcome Measures
NameTimeMethod
pathologic complete response rate (pCR)through study completion, an average of 6 months

ypT0/isNx

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Peking University Cancer Hospital

🇨🇳

Haidian, Beijing, China

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