Short-course Trastuzumab, Pertuzumab With Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer

Study Overview
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Brief Summary
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We 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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Pertuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pertuzumab<br>4 cycles of taxane, Pertuzumab, Trastuzumab | Drug: Pertuzumab<br>* 4 cycles of taxane, pertuzumab, trastuzumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival [OS] | Time from surgery to death from any cause | 3 year | 
| Distant disease-free survival [DDFS] | Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause | 3 year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, pertuzumab, her2, adjuvant