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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2021
  • participants needed
    550
  • sponsor
    Fudan University
Updated on 23 January 2021
paclitaxel
carcinoma
anthracyclines
metastasis
capecitabine
HER2
trastuzumab
erbb2
vinorelbine
cish
immunostimulant
ductal carcinoma
chromogenic in situ hybridization

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

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Capecitabine, Vinorelbine
Clinical Study IdentifierNCT04302441
SponsorFudan University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or cancer, breast or Breast Cancer Diagnosis or breast carcinoma?
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 count3000/L,neutrophil count 1500/L, hemoglobin 9g/dL and platelet count 75000/L
Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) 1.5upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) 2.5ULN, 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
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