A Real-World Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy

Hebei Medical University

Status: Begins enrollment in 1 month

Conditions: Early Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07540520

RWS

Details and patient eligibility

About

This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically confirmed HER2-positive breast cancer (i.e., immunohistochemistry (IHC) staining result of 3+, or HER-2 2+ with fluorescence in situ hybridization showing HER-2 gene amplification);
• Received neoadjuvant therapy with chemotherapy combined with trastuzumab before surgery: including at least 6 cycles of chemotherapy, with at least 4 cycles of taxane-based chemotherapy; and at least 4 cycles of trastuzumab treatment (including trastuzumab biosimilars and subcutaneous formulations);
• Completion of radical surgery, postoperative pathology confirms the presence of invasive carcinoma in the breast and/or axillary lymph nodes after neoadjuvant therapy.
• Hormone receptor status is known.

Exclusion criteria

• Combine other systemic malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
• Stage IV metastatic breast cancer;
• Incomplete clinical pathology and follow-up data; Study endpoints

Trial design

2,000 participants in 2 patient groups

HP

Description:

The trastuzumab combined with pertuzumab group

T-DM1

Description:

The ado-trastuzumab emtansine group