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A Multicenter Study for HER2 Low-Expression Early-Stage Breast Cancer Patients, and Biomarker Analysis

A Multicenter Study of Clinicopathological Characteristics and Prognostic Factors in Patients with HER2-Low Early-Stage Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046766
Enrollment
Unknown
Registered
2021-05-28
Start date
2021-05-17
Completion date
Unknown
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

case series:N/A

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Female patients with histologically-confirmed diagnosed with early-stage invasive breast cancer; 2. Complete clinicopathological information and follow-up until December 2020; 3. HER2 expression is measured by IHC with CFDA approved reagents.The 2013 ASCO/CAP HER2 guidelines provide standards for determining HER2 status; 4. HER2 staining showed HER2 low-expressing(IHC1 + or IHC2 + /-); 5. Patients received completion resection of primary breast tumor; 6. Patients received standard systemic treatment with reference to the Guidelines, such as Chinese Anti-Cancer Association guidelines (2013 Edition) or NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 1. 2014, including adjuvant/(neoadjuvant) chemotherapy for >= 4 cycles, receiving endocrine therapy if indicated.

Exclusion criteria

Exclusion criteria: 1. First diagnosis of stage IV or metastatic breast cancer; 2. Failure to complete the expected systemic treatment; 3. Past tumor treatment history; 4. Bilateral breast cancer.

Design outcomes

Primary

MeasureTime frame
Disease Free Survival;Overall Survival;

Countries

China

Contacts

Public ContactLiu Yinhua

Peking University First Hospital

liuyinhua7520@163.com+86 10 83575053

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026