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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

Sponsor
Tao OUYANG (Other)
Overall Status
Recruiting
CT.gov ID
NCT03270007
Collaborator
(none)
304
Enrollment
1
Location
2
Arms
85.7
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 10, 2017
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chemotherapy

Drug: Vinorelbine
different from primary chemotherapy(containing anthracycline or paclitaxel)
Other Names:
  • Intensive treatment

    		•
    No Intervention: Control

    Outcome Measures

    Primary Outcome Measures

    1. distant disease-free survival (DDFS) [5 years after surgery]

    Secondary Outcome Measures

    1. relapse-free survival（RFS）、overall survival（OS） [5 years after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 66 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female patients, 18≦age ≦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:

    1. Absolute neutrophil count (ANC) ≥1500/mm3

    2. Platelets ≥100,000/ mm3

    3. Hemoglobin ≥10 g/dL

    • Adequate hepatic and renal function with:

    1. Serum bilirubin ≤1.5×UNL

    2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)

    3. BUN between 1.7 and 8.3 mmol/L

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Cancer Hospital Beijing Beijing China 100142

    Sponsors and Collaborators

    • Tao OUYANG

    Investigators

    • Principal Investigator: Xing Wang, MD, Peking University Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tao OUYANG, Chairman of Breast Center, Peking University
    ClinicalTrials.gov Identifier:
    NCT03270007
    Other Study ID Numbers:
    • BCP19
    First Posted:
    Sep 1, 2017
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Vinorelbine

    Study Results

    No Results Posted as of Oct 28, 2020