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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

ConditionEarly Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHebei Medical University Fourth Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

The planned total number of cases is 2000.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 2 trial groups
Group A: HP
Group B: T-DM1

Trial outcomes

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.

Time frame
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

1

3-year iDFS rate in Near-pCR patients:

3-year iDFS rate in Near-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 in Near-pCR patients (Near-pCR is defined as Miller \& Payne grade 4, MP5 with invasive cancer present in axillary lymph nodes, RCB1).

Time frame
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.
2

Overall survival

Overall Survival (OS) refers to the length of time from either the date of diagnosis or the start of treatment for a disease (such as cancer) until death from any cause.

Time frame
It is a direct measure of the treatment's ultimate impact on patient survival.
3

Adverse Events

Safety refers to the assessment of adverse events (AEs) and potential risks associated with a medical intervention (e.g., drug, device, procedure)

Time frame
From date of enrollment until adjuvant therapy after surgery 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebei Medical University Fourth Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: