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
NCT ID: NCT03270007
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
304 participants
INTERVENTIONAL
2017-11-10
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chemotherapy
Vinorelbine
different from primary chemotherapy(containing anthracycline or paclitaxel)
Control
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vinorelbine
different from primary chemotherapy(containing anthracycline or paclitaxel)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
66 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tao OUYANG
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tao OUYANG
Chairman of Breast Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xing Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Wang X, He Y, Li J, Wang T, Fan Z, Ouyang T. Intensive treatment of triple negative breast cancer with residual positive axillary lymph node after neoadjuvant chemotherapy. BMC Womens Health. 2024 Nov 27;24(1):629. doi: 10.1186/s12905-024-03441-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCP19
Identifier Type: -
Identifier Source: org_study_id