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

NCT07376174 | Recruiting

• 1 other identifier: SDTHEC202601024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; HER2/CEP17 Ratio

Keywords

HER2/CEP17 ratio; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival based on HER2/CEP17 ratio

  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.

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

Study Arms (2)

HER2 FISH ultra

HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer

HER2 FISH normal

HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2-positive patients with breast cancer were enrolled between January 2020 and December 2023.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Department of Medical Oncology

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fangchao Zheng, MD

CONTACT

86-67627005; sgzhfch@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 29, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (1)