Clinical trial · Interventional
Docetaxel in Treating Patients With Metastatic Breast Cancer
Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer
NCT00008411CI-TRIAL-00007622completedPhase 3ClinicalTrials.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 III trial to determine the effectiveness of docetaxel 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel Weekly
- description
- Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
- interventionNames
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Docetaxel Every 3 Weeks
- description
- Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Objective Tumor Response Rate
- timeFrame
- Weekly
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * Bidimensionally measurable disease * No uncontrolled brain metastases or leptomeningeal disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Neutrophil count at least 1,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN) * Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN) Renal: * Creatinine no greater than 2.0 mg/dL Neurologic: * No peripheral neuropathy grade 2 or greater * Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis * No psychiatric disorders Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy * No other serious condition or illness, including active infection * No history of hypersensitivity to polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Recovered from prior chemotherapy * No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease) * No prior paclitaxel or docetaxel (except in the adjuvant setting) * At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel) * Prior anthracycline-based therapy allowed Endocrine therapy: * Not specified Radiotherapy: * At least 2 weeks since prior radiotherapy and recovered Surgery: * At least 2 weeks since prior surgery and recovered
References
Publications (1)
- RESULTRivera E, Mejia JA, Arun BK, Adinin RB, Walters RS, Brewster A, Broglio KR, Yin G, Esmaeli B, Hortobagyi GN, Valero V. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008 Apr 1;112(7):1455-61. doi: 10.1002/cncr.23321. PMID 18300256