The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy

Previous studies suggest that among patients receiving trastuzumab monotherapy, a HER2/CEP17 ratio >7.0 (ultra-high expression) is associated with poorer disease-free survival (DFS). Dual-target therapy (trastuzumab + pertuzumab) has become the standard treatment for high-risk HER2-positive breast cancer; however, whether it can predict outcomes in patients with ultra-high HER2 expression remains unsupported by clinical data. To analyze the clinicopathological characteristics and prognostic relationship between the HER2 ultra-high expression group and the normal expression group in non-metastatic HER2-positive breast cancer patients who received dual-target therapy.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms HER2/CEP17 Ratio Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Medical Oncology

Jinan, Shandong, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years.
Pathologically confirmed primary breast cancer, clinical stage I-III (AJCC 8th Edition).
HER2-positive status confirmed by FISH testing (per ASCO/CAP guidelines) with available HER2/CEP17 ratio.
Received at least one dose of dual-target therapy (trastuzumab combined with pertuzumab) in the adjuvant or neoadjuvant setting.
Underwent curative-intent surgery (mastectomy or breast-conserving surgery).

Exclusion criteria

Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis.
Previous anti-HER2 targeted therapy prior to dual-target treatment.
Missing key clinical data (e.g., HER2 FISH results, treatment regimen, surgery date).
Carcinoma in situ or occult breast cancer, non-primary breast cancer, or concurrent other malignancies.
Loss to follow-up or follow-up duration <3 months (unless recurrence or death occurred within this period).

Treatment and study plan

Primary outcomes

Disease-free survival based on HER2/CEP17 ratio

Time frame: From the date of pathological diagnosis to event with follow-up duration ≥3 months (unless recurrence or death occurred within 3 month).

Defined as the period from the date of pathological diagnosis until the date of the first relapse, appearance of non-breast primary cancer, death with no signs or symptoms of recurrence or metast, or the last recorded follow-up ,whichever came first.

Study contacts

Contact information is provided by the study sponsor or research team.

Fangchao Zheng, MD

CONTACT

[email protected]

86-67627005

Sponsors and collaborators

Lead sponsor

Shandong Cancer Hospital and Institute

Other

Registry information

Official study title

A Multicenter Retrospective Cohort Study Protocol on the Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 29, 2026
Registry last updated: Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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