Breast Cancer Clinical Trial
Official title:
Short-course Trastuzumab, Pertuzumab Combined With Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm Study
The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease - HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines - complete clinical pathological information - Eastern Cooperative oncology Group [ECOG] 0-1 - Currently not pregnant or breast-feeding - Fine organ function - Have good compliance with planned treatment, understand the study process and sign a written informed consent Exclusion Criteria: - Bilateral or metastatic breast cancer - Receiving neoadjuvant treatment - Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer - Severe systemic infections or other serious illnesses - HIV infection, active hepatitis B or C infection - Known allergy to or intolerance to a therapeutic drug or its excipients - Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason - Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment - Receiving live vaccine within 30 days prior to initial administration of the investigational treatment - History of mental illness or drug abuse that may affect compliance with the trial requirements - The researchers determine that the patients were not suitable for the study |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival [DFS] | Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause | 3 year | |
Secondary | Overall survival [OS] | Time from surgery to death from any cause | 3 year | |
Secondary | Distant disease-free survival [DDFS] | Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause | 3 year | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 year |
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