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

NCT05673850 | Completed

• 1 other identifier: ASSOCIHER
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• pathologic complete response rate (pCR)

  ypT0/isNx

  through study completion, an average of 6 months

Study Arms (2)

NET

Drug: NET or NCT

NCT

Drug: NET or NCT

Interventions

NET or NCT DRUG

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

NCT; NET

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Haidian, Beijing Municipality, 000013, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: January 6, 2023
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 6, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)