Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
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
- The protocol lists: Pertuzumab.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 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
- China
- 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
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
Overview
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.
Interventions
- Drug Pertuzumab
4 cycles of taxane, pertuzumab, trastuzumab
Primary outcome measures
- Disease free survival [DFS] [Time frame: 3 year]
Secondary outcome measures (3)
- Overall survival [OS] [Time frame: 3 year]
- Distant disease-free survival [DDFS] [Time frame: 3 year]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 3 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital — Shanghai
Identifiers
NCT: NCT05891561 · RJBC-THP4