Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

Study Overview
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Brief Summary
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This is a prospective, open-lable Phase II clinical trial (ORCHID study) evaluating the effectiveness and safety of oral vinorelbine or capecitabine combined with trastuzumab as adjuvant treatment for patients with lymph node negative, HER-2 positive and small tumor size breast cancer

Official Title
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A Phase II Study to Assess the Effectiveness and Safety of Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Vinorelbine
* Drug: Capecitabine
* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 18-70 years old; T ≤1cm and negative lymph node confirmed by histopathology after early breast cancer surgery HER2 positive confirmed by histopathology after early breast cancer surgery（HER2-positive breast cancer defined as a positive in situ hybridization test or an Immunohistochemistry (IHC) status of 3+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) , or Silver in situ hybridization (SISH)) test is required by local laboratory testing.) Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula). Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. Exclusion Criteria: Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）; Has bilateral breast cancer; Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. Has metastic (Stage 4) breast cancer; Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; Patients participating in other clinical trials at the same time; Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; Has severe or uncontrolled infection; Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders; the researchers judged patients to be unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single arm<br>6 cycle of oral vinorelbine or capecitabine combined with trastuzumab (21 days per cycle), followed by sequential single trastuzumab to 1 year | Drug: Vinorelbine<br>* Vinorelbine chemotherapy (oral)<br>Drug: Capecitabine<br>* Capecitabine chemotherapy (oral)<br>Drug: Trastuzumab<br>* Trastuzumab target therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distant disease free survival |  | 5 year | 
| overall survival |  | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral vinorelbine, capecitabine, trastuzumab, adjuvant treatment