A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab for HER2 Positive Patients Following Neoadjuvant Chemotherapy
1 other identifier
interventional
550
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Nov 2016
Typical duration for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2016
CompletedFirst Submitted
Initial submission to the registry
March 7, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedMarch 10, 2020
March 1, 2020
4.6 years
March 7, 2020
March 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Recurrence free survival
3 year
Distant disease free survival
3 year
Overall survival
5=3 year
Study Arms (2)
NXH group
EXPERIMENTALPatients 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).
H group
NO INTERVENTIONPatients should receive trastuzumab at 6mg/kg iv infusion on day1 every 3 weeks to 1 year.
Interventions
Eligibility Criteria
You may qualify if:
- 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%.
- +3 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhi-Ming Shao
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 7, 2020
First Posted
March 10, 2020
Study Start
November 10, 2016
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share