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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Early Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Three-year invasive disease-free survival (iDFS) rate for non-pCR patients [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 outcome measures (3)
- 3-year iDFS rate in Near-pCR patients: [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.]
- Overall survival [Time frame: It is a direct measure of the treatment's ultimate impact on patient survival.]
- Adverse Events [Time frame: From date of enrollment until adjuvant therapy after surgery 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07540520 · RWS