Clinical trial · Interventional
Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer
A Doublelet Metronomic Chemotherapeutic Regimen With Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer Patients: A Monocentric Retrospective Study in China
NCT05747326CI-TRIAL-00064306unknownPhase 2ClinicalTrials.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 study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral vinorelbine and capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles.
- interventionNames
- Drug: oral vinorelbine and capecitabine
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- At 1 year
- description
- 1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * female; * aged ≥ 18 years and ≤75 years; * histologically proved metastatic HER-2 negative breast cancer. HER2-negative status determined by situ hybridization (FISH) or immunohistochemistry (IHC) (IHC 0, 1+, 2+ and/or FISH HER2 negative); * at least one measurable or evaluable lesion based on RECIST 1.1 criteria; * estimated life expectancy ≥ 3 months; * normal heart, liver, and kidney function; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; * informed consent signed by the participants Exclusion Criteria: * received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation; * participated in other new drug clinical trials within 4 weeks before enrollment; * inflammatory breast cancer; * symptomatic visceral disease; * second primary malignancy; * mental disorder.
References
Publications (1)
- DERIVEDChai Y, Liu J, Jiang M, He M, Wang Z, Ma F, Wang J, Yuan P, Luo Y, Xu B, Li Q. A phase II study of a doublet metronomic chemotherapy regimen consisting of oral vinorelbine and capecitabine in Chinese women with HER2-negative metastatic breast cancer. Thorac Cancer. 2023 Aug;14(23):2259-2268. doi: 10.1111/1759-7714.15011. Epub 2023 Jul 4. PMID 37402471