A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab for HER2 Positive Patients Following Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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This study aims to evaluate vinorelbine plus capecitabine combined with trastuzumab versus trastuzumab alone as the adjuvant Treatment of HER2 positive patients following neoadjuvant chemotherapy

Official Title
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A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab as the Adjuvant Treatment of HER2 Positive Patients Following Neoadjuvant Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Vinorelbine
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 70 years old Patients with histologically confirmed unilateral invasive ductal carcinoma(according to WHO histologically type) Tumor clinical staged as IIB-IIIB before neoadjuvant chemotherapy (according to the 7th AJCC edition). After standard treatment (at least 6 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs combined with trastuzumab), assessed by the surgery, the original site for non - pCR (MP class 1-4) or lymph nodes are still positive for patients. No gross or microscopic tumor residual after resection. Patients with Her2 receptor positive (Specific definition: immunohistochemical detection of Her2 3+ or Her2 2 + but after FISH or CISH tested is positive). No evidence of distant metastasis in the clinical or radiological aspects of preoperative. examination,that is M0. Patients without peripheral neuropathy or I peripheral neurotoxicity. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1. Patients recovered well after surgery, at least 1 weeks after the operation. Adequate marrow: White blood cells count≥3000/μL,neutrophil count ≥1500/μL, hemoglobin ≥9g/dL and platelet count ≥75000/μL. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN. Adequate renal function: Serum creatinine ≤ 1.5ULN. Contraception during the treatment of child-bearing women. Adequate cardiac function :Left ventricular ejection fraction (LVEF) > 50%. Patients must be informed of the investigational nature of this study and give written informed consent. Patients without serious heart, lung, liver, kidney and other important organs disease history. Patients have good compliance. Exclusion Criteria: Patients with bilateral breast cancer or carcinoma in situ(DCIS/LCIS). Metastasis of any part except axillary lymph nodes. Clinical or imaging suspicion of the contralateral breast is malignant but not confirmed, requiring biopsy. There have been malignant tumors (except for basal cell carcinoma and carcinoma in situ of cervix) in the last five years, including breast cancer. Patients have been enrolled in other clinical trials. Patients with severe systemic illnesses and/or uncontrolled infections are unable to join the study. Patients with severe cardio-cerebrovascular disorders (e.g., unstable angina pectoris, chronic heart failure, uncontrollable hypertension >160/100mmgh, myocardial infarction or cerebrovascular accident) in the first 6 months of randomization. Pregnant lactating women (child-bearing women must be negative for pregnancy test within 14 days prior to first delivery, if positive, the pregnancy should be excluded by ultrasound.) Child-bearing women who are unwilling to take effective contraceptive measures in the course of research. Patients with mental illness, cognitive impairment, inability to understand test protocols and side effects, and those who fail to complete the trial programme and follow-up work (a systematic assessment is required before the trial). Persons without personal freedom and independent civil capacity.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NXH group<br>Patients should receive four cycles of NXH regimen (vinorelbine at 25 mg/m2 iv infusion on day 1 and day 8 plus capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle, trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year). | Drug: Vinorelbine<br>* vinorelbine 25mg/m2 on day 1 and 8,every 3 weeks<br>Drug: Capecitabine<br>* Capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle<br>|
| No Intervention: H group<br>Patients should receive trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival | Recurrence free survival is calculated from surgery to the first recurrence | 3 year | 
| Distant disease free survival | Distant disease free survival is calculated from surgery to the first distant metastasis. | 3 year | 
| Overall survival | Overall survival is calculated from randomization to death from any cause. | 5=3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-pCR, HER2 positive, vinorelbine, capecitabine