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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05673850
• Other study ID #: ASSOCIHER
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• NET or NCT
In this study, we included 518 ER-positive BC patients who received either neoadjuvant endo-crine therapy (NET) or neoadjuvant chemotherapy (NCT).

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Haidian	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response rate (pCR)	ypT0/isNx	through study completion, an average of 6 months