Clinical trial · Interventional
Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer
NCT00093808CI-TRIAL-00026288completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Giving capecitabine and vinorelbine together with trastuzumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- capecitabine + vinorelbine + trastuzumab
- description
- Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10 minutes on days 1 and 8, and trastuzumab (Herceptin\^®) IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
- interventionNames
- Biological: trastuzumab
- Drug: capecitabine
- Drug: vinorelbine tartrate
Primary outcomes (1)
- measure
- Confirmed Response Rate
- timeFrame
- Up to 5 years
- description
- A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed invasive breast cancer
* Metastatic disease
* HER2/neu-positive by immunohistochemistry (3+ by HercepTest\^™ or equivalent) OR positive for amplification by fluorescent in situ hybridization
* Testing may be performed in the primary tumor or the metastatic site
* Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease
* Measurable disease
* At least one measurable lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan
* The following are considered non-measurable disease:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* No bone metastases as the only evidence of metastasis
* Previously treated CNS metastases allowed provided disease has been stable for ≥ the past 3 months
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female or male
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* No known uncontrolled coagulopathy
Hepatic
* Bilirubin ≤ 3.0 times the upper limit of normal (ULN)
* One of the following must be true:
* AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
* Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
* Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* INR ≤ 1.5 times ULN
Renal
* Calcium ≤ 11.5 mg/dL
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 30 mL/min
Cardiovascular
* LVEF ≥ 50% by MUGA or echocardiogram
* No clinically significant (i.e., active) cardiac disease
* No congestive heart failure
* No symptomatic coronary artery disease
* No myocardial infarction within the past 12 months
* No cardiac arrhythmia not controlled with medication
Gastrointestinal
* Able to take oral medication
* No lack of physical integrity of the upper gastrointestinal tract
* No clinically significant malabsorption syndrome
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 30 days after study participation
* No history of allergy or hypersensitivity to study drugs, drug product excipients, including polysorbate 80, or chemically similar agents
* No prior unanticipated severe reaction to fluoropyrimidine therapy
* No know hypersensitivity to fluorouracil
* No known dihydropyrimidine dehydrogenase deficiency
* No history of uncontrolled seizures or CNS disorders
* No clinically significant psychiatric disability that would preclude giving informed consent or study compliance
* No other serious uncontrolled infection or disease
* No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior adjuvant trastuzumab (Herceptin\^®) allowed as adjuvant or first-line therapy for metastatic disease
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* No more than 1 prior chemotherapy regimen in the advanced or metastatic (non-adjuvant) setting
* No prior continuous (≥ 24 hours) fluorouracil infusion
* No prior capecitabine
* No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and tegafur, S1, or emitefur)
Endocrine therapy
* At least 1 day since prior hormonal therapy
* No concurrent hormonal therapy
Radiotherapy
* More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal column, sternum, or ribs)
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior major surgery
* No prior organ allografts requiring immunosuppressive therapy
Other
* More than 4 weeks since prior investigational drugs
* No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
* No concurrent allopurinol, metronidazole, or cimetidine
* No other concurrent cytotoxic agents
* No other concurrent investigational drugs
* No other concurrent anticancer therapyReferences
Publications (2)
- RESULTTan WW, Allred JB, Salim M, Flynn P, Fishkin PA, Stella PJ, Wiesenfeld M, Bernath AM, Fitch TR, Perez EA. Phase II interventional study (N0337) of capecitabine in combination with vinorelbine and trastuzumab for first- or second-line treatment of HER2-positive metastatic breast cancer: a north central cancer treatment group trial. Clin Breast Cancer. 2012 Apr;12(2):81-6. doi: 10.1016/j.clbc.2012.01.001. PMID 22444716
- DERIVEDChumsri S, Sperinde J, Liu H, Gligorov J, Spano JP, Antoine M, Moreno Aspitia A, Tan W, Winslow J, Petropoulos CJ, Chenna A, Bates M, Weidler JM, Huang W, Dueck A, Perez EA. High p95HER2/HER2 Ratio Associated With Poor Outcome in Trastuzumab-Treated HER2-Positive Metastatic Breast Cancer NCCTG N0337 and NCCTG 98-32-52 (Alliance). Clin Cancer Res. 2018 Jul 1;24(13):3053-3058. doi: 10.1158/1078-0432.CCR-17-1864. Epub 2018 Mar 12. PMID 29530935