A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab for HER2 Positive Patients Following Neoadjuvant Chemotherapy
- Registration Number
- NCT04302441
- Lead Sponsor
- Fudan University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 550
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NXH group Vinorelbine 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). NXH group Capecitabine 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).
- Primary Outcome Measures
Name Time Method Disease free survival 3 year The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
- Secondary Outcome Measures
Name Time Method Overall survival 5=3 year Overall survival is calculated from randomization to death from any cause.
Recurrence free survival 3 year Recurrence free survival is calculated from surgery to the first recurrence
Distant disease free survival 3 year Distant disease free survival is calculated from surgery to the first distant metastasis.
Trial Locations
- Locations (1)
Breast cancer institute of Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China