Clinical trial · Interventional
Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
NCT00015886CI-TRIAL-00034309completedPhase 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 II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.
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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
- timeFrame
- 28 weeks
Secondary outcomes (1)
- measure
- To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil
- timeFrame
- 28 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic or unresectable local disease * Measurable or evaluable disease * No ascites or pleural effusion as only metastatic site * No brain or leptomeningeal metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * 0-2 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count greater than 1,500/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin normal * SGOT/SGPT less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * Adequate cardiac function * No history of significant atherosclerotic coronary disease (e.g., uncontrolled angina) * No history of significant cardiac arrhythmia Other: * No serious medical or psychiatric illness that would preclude study * No active uncontrolled bacterial, viral, or fungal infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior high-dose chemotherapy and autologous transplantation Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy) * No prior docetaxel * No prior high-dose chemotherapy and autologous transplantation * Prior paclitaxel allowed Endocrine therapy: * No concurrent hormonal therapy, except as contraception Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered * Concurrent radiotherapy for relief of localized pain or obstruction allowed Surgery: * At least 2 weeks since prior major surgery and recovered Other: * No other concurrent cytotoxic agents
References
Publications (0)
Data not yet available
No reference posted for this study.