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NCT05673850

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

Completed Last updated 6 January 2023
What this trial tests

trial testing NET or NCT in Breast Neoplasms in 518 participants. Completed in 1 October 2022.

Timeline
1 May 2022
Primary endpoint
1 August 2022
1 October 2022

Quick facts

Lead sponsorPeking University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment518
Start date1 May 2022
Primary completion1 August 2022
Estimated completion1 October 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking University

Who can join

Eligibility, any sex, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

Other Peking University trials

Trials by the same sponsor.

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Data sources for this page

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