Clinical trial · Interventional
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
NCT03270007CI-TRIAL-00047954unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase IV, single-center, prospective, open-label, randomized,controlled study
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- interventionNames
- Drug: Vinorelbine
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- distant disease-free survival (DDFS)
- timeFrame
- 5 years after surgery
Secondary outcomes (1)
- measure
- relapse-free survival(RFS)、overall survival(OS)
- timeFrame
- 5 years after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 66 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWang 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. PMID 39604957