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

December 30, 2022 updated by: Peking University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

518

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Haidian, Beijing, China, 000013
        • Peking university cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In this retrospective cohort study, we sourced data from the electronic database of Peking university cancer hospital to identify patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021. Patients were excluded by the fol-lowing criteria: (1) patients who were ER-negative; (2) patients who were HER2 posi-tive defined as IHC3+ or IHC2+/fluorescence in situ hybridization (FISH)-positive; (3) patients who were HER2 (IHC2+) but did not evaluate by further FISH;(4) patients who did not receive neoadjuvant therapy; (5) patients who received concurrent neo-adjuvant endocrine and chemotherapy. Patients who remained were further divided into two groups: those receiving neoadjuvant endocrine therapy (the NET group) and those receiving neoadjuvant chemotherapy (the NCT group).

Description

Inclusion Criteria:

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

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NET
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).
NCT
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologic complete response rate (pCR)
Time Frame: through study completion, an average of 6 months
ypT0/isNx
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

November 27, 2022

First Submitted That Met QC Criteria

December 30, 2022

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASSOCIHER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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