Clinical trial · Interventional
Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer
NCT00026442CI-TRIAL-00013049unknownPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or 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 |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically and/or cytologically confirmed breast cancer * Advanced and/or metastatic disease * At least 1 measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present) * No hepatitis Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 50 mL/min Cardiovascular: * No clinically significant cardiac disease * No congestive heart failure * No symptomatic coronary artery disease * No cardiac arrhythmias poorly controlled with medication * No myocardial infarction within the past 12 months even if adequately controlled with medication Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No severe pain inadequately controlled by analgesics * No prior severe and unexpected reaction to fluoropyrimidine therapy * No known hypersensitivity to fluorouracil * No impaired physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * No inability to swallow tablets * No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation * No serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 2 but no more than 3 prior chemotherapy regimens * At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field * No concurrent radiotherapy Surgery: * No prior organ allografts Other: * At least 4 weeks since prior investigational drug * No concurrent enrollment on other investigational study * No other concurrent anticancer agents
References
Publications (0)
Data not yet available
No reference posted for this study.