Clinical trial · Interventional
Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
NCT00006120CI-TRIAL-00001600unknownPhase 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 regimens of docetaxel or paclitaxel in treating women who have unresectable locally 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven unresectable locally advanced or metastatic breast cancer * Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines * At least one bidimensionally measurable lesion * No brain metastasis * No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease * Hormone receptor status: * Known hormone receptor status PATIENT CHARACTERISTICS: Age: * 18 to 75 Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * Bilirubin normal Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No uncontrolled angina or arrhythmia * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart disease Other: * No sensitive neuropathy worse than grade 2 * No other significant, uncontrolled medical or psychiatric condition * No serious active infection * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior specific antitumoral immunotherapy Chemotherapy: * See Disease Characteristics * No prior taxanes * At least 4 weeks since other prior specific antitumoral chemotherapy Endocrine therapy: * At least 4 weeks since prior specific antitumoral hormonal therapy Radiotherapy: * At least 4 weeks since prior specific antitumoral radiotherapy Surgery: * Not specified Other: * No other concurrent experimental medication
References
Publications (0)
Data not yet available
No reference posted for this study.