Clinical trial · Observational

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

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

NCT07540520CI-TRIAL-00108780not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Early Breast Cancer	Breast Neoplasm	ONTOLOGY_EXACT	0.90

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
HP
description
The trastuzumab combined with pertuzumab group
label
T-DM1
description
The ado-trastuzumab emtansine group

Primary outcomes (1)

measure
Three-year invasive disease-free survival (iDFS) rate for non-pCR patients
timeFrame
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.
description
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.

Secondary outcomes (3)

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

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.