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

NCT07540520 | Not Yet Recruiting

• 1 other identifier: RWS
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Three-year invasive disease-free survival (iDFS) rate for non-pCR patients

  iDFS events include local and regional recurrence, distant metastasis, contralateral invasive breast cancer, second non-breast primary cancer (excluding non-invasive carcinoma in situ), and death from any cause at 3 years.

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

Secondary Outcomes (3)

• 3-year iDFS rate in Near-pCR patients:

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

• Overall survival

  It is a direct measure of the treatment's ultimate impact on patient survival.

• Adverse Events

  From date of enrollment until adjuvant therapy after surgery 1 year

Study Arms (2)

HP

The trastuzumab combined with pertuzumab group

T-DM1

The ado-trastuzumab emtansine group

Eligibility Criteria

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

Study Population

The planned total number of cases is 2000.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): August 2, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04