Clinical trial · Interventional
Capecitabine in Treating Patients With Metastatic Breast Cancer
Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer
NCT00274768CI-TRIAL-00043029completedPhase 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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine
- description
- 26 patients received the pre-defined starting dose of capecitabine of 3,000 mg orally daily given in two divided doses. Two thirds of the patients received either the same dose or a 500 mg lower dose compared to what would have been administered with a commonly used body surface area (BSA)-dosing schedule (2,000 mg/m2 with rounding down to nearest 500 mg multiple).
- interventionNames
- Drug: capecitabine
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- Participants were followed to progression, evaluated every 12 weeks
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast * Evidence of metastatic involvement (stage IV disease) * Patients must have measurable disease * At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) * Treated brain metastases (surgery or radiation therapy) allowed if clinically stable * Patients with leptomeningeal disease are ineligible * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Male or female * Menopausal status not specified * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine clearance \> 50 mL/min * Fertile patients must use effective contraception * No history of another severe and/or life-threatening medical disease * No other active primary malignancy * Not pregnant or nursing * Negative pregnancy test * Patients with asymptomatic HIV infection are eligible * Liver dysfunction score ≤ 9 * No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis) * No active gastrointestinal malabsorption illness * No clinically significant cardiac disease, including the following: * Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months * No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency * No history of uncontrolled seizures or central nervous system disorders * No significant history of noncompliance to medical regimens * No clinically significant psychiatric disability that would preclude study compliance PRIOR CONCURRENT THERAPY: * No previous capecitabine * Up to 3 prior cytotoxic regimens allowed for metastatic disease * Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab) * No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy * No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy * No other concurrent investigational drugs * No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT) * Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed * At least 4 weeks since prior sorivudine or brivudine * Concurrent use of bisphosphonates allowed if initiated before beginning study therapy * Concurrent use of megestrol acetate suspension as an appetite stimulant allowed
References
Publications (1)
- DERIVEDFackler MJ, Lopez Bujanda Z, Umbricht C, Teo WW, Cho S, Zhang Z, Visvanathan K, Jeter S, Argani P, Wang C, Lyman JP, de Brot M, Ingle JN, Boughey J, McGuire K, King TA, Carey LA, Cope L, Wolff AC, Sukumar S. Novel methylated biomarkers and a robust assay to detect circulating tumor DNA in metastatic breast cancer. Cancer Res. 2014 Apr 15;74(8):2160-70. doi: 10.1158/0008-5472.CAN-13-3392. PMID 24737128