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

• Sponsor: Peking University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05673850
• Collaborator: (none)
• Enrollment: 518
• Location: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 103

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: NET or NCT

Study Design

• Study Type: Observational
• Actual Enrollment: 518 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy
• Actual Study Start Date: May 1, 2022
• Actual Primary Completion Date: Aug 1, 2022
• Actual Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. pathologic complete response rate (pCR) [through study completion, an average of 6 months]

   ypT0/isNx

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	Haidian	Beijing	China	000013

Sponsors and Collaborators

• Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University
• ClinicalTrials.gov Identifier: NCT05673850
• Other Study ID Numbers: ASSOCIHER
• First Posted: Jan 6, 2023
• Last Update Posted: Jan 6, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jan 6, 2023