Clinical trial · Interventional
Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer
NCT00031876CI-TRIAL-00006916completedPhase 1 / Phase 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to determine the effectiveness of combining capecitabine and paclitaxel 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
* Patients in phase I:
* Evaluable disease
* Patients in phase II:
* Bidimensionally measurable disease
* Bone metastases are not considered measurable
* No known or clinically suspected CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 to 64
Sex:
* Not specified
Menopausal status:
* Not specified
Performance status:
* WHO 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC greater than 3,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2 times ULN (3 times ULN if liver metastases present)
Renal:
* Patients in phase I:
* Creatinine clearance at least 50 mL/min
* Patients in phase I or II:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No grade 2 or greater atrioventricular block
Other:
* No cognitive impairment or severe psychiatric disorder
* No greater than grade 2 preexisting peripheral neuropathy
* No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* Able to tolerate steroid premedication
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* More than 6 months since prior adjuvant chemotherapy
* At least 1 year since prior continuous infusion of fluorouracil or capecitabine
* At least 1 year since prior taxane administered once every 3 weeks
* No prior taxane or capecitabine administered weekly
* No more than 1 prior chemotherapy regimen for metastatic or locally advanced breast cancer
* No other concurrent chemotherapy
Endocrine therapy:
* Prior hormonal treatment for metastatic breast cancer allowed
* No concurrent continuous glucocorticosteroids
* No concurrent systemic endocrine treatment for breast cancer
Radiotherapy:
* No concurrent radiotherapy to indicator lesion or more than 30% of bone marrow
Surgery:
* Not specified
Other:
* No other concurrent anticancer treatment
* No concurrent immunosuppressive drugs
* Concurrent bisphosphonates allowed if indicator lesion is non-bone
* Able to tolerate steroid premedicationReferences
Publications (2)
- RESULTGick U, Rochlitz C, Mingrone W, Pestalozzi B, Rauch D, Ballabeni P, Lanz D, Hess V, Aebi S. Efficacy and tolerability of capecitabine with weekly paclitaxel for patients with metastatic breast cancer: a phase II report of the SAKK. Oncology. 2006;71(1-2):54-60. doi: 10.1159/000100449. Epub 2007 Mar 5. PMID 17344671
- RESULTUhlmann C, Ballabeni P, Rijken N, Brauchli P, Mingrone W, Rauch D, Pestalozzi BC, Rochlitz C, Aebi S; Swiss Group for Clinical Cancer Research; Swiss Institute for Applied Cancer Research. Capecitabine with weekly paclitaxel for advanced breast cancer: a phase I dose-finding trial. Oncology. 2004;67(2):117-22. doi: 10.1159/000080997. PMID 15539915