Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    304
  • sponsor
    Tao OUYANG
Updated on 26 January 2021

Summary

This is a phase IV, single-center, prospective, open-label, randomized,controlled study

Details
Condition Primary Breast Cancer
Treatment Vinorelbine
Clinical Study IdentifierNCT03270007
SponsorTao OUYANG
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients, 18age 66 years
Biopsy proven lymph node positive, estrogen receptor<10%progesterone receptor <10% and human epidermal growth factor receptor-2 negative primary breast cancer
Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel)
Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
Postoperative residual positive lymph nodes
Adequate recovery from recent surgery
No history of other malignancies
No currently uncontrolled diseased or active infection
Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
Adequate cardiovascular function reserve with a myocardial infarction within the past six month
without radiotherapy and chemotherapy contraindication
Adequate hematologic function with
Absolute neutrophil count (ANC) 1500/mm3
Platelets 100,000/ mm3
Hemoglobin 10 g/dL
Adequate hepatic and renal function with
Serum bilirubin 1.5UNL
Alkaline phosphatase and alanine aminotransferase (ALT) 2.5 x ULN. (5 x ULN is acceptable in the setting of hepatic metastasis)
BUN between 1.7 and 8.3 mmol/L
Cr between 40 and 110 umol/L
Knowledge of the investigational nature of the study and Ability to give informed consent
Ability and willingness to comply with study procedures

Exclusion Criteria

Known or suspected distant metastases
Concurrent malignancy or history of other malignancy
Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
Geographical, social, or psychological problems that would compromise study compliance
Known or suspected hypersensitivity to vinorelbine
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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