Clinical trial · Interventional
Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
NCT00026078CI-TRIAL-00011663unknownPhase 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: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women 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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (5)
- measure
- Time to treatment failure
- measure
- Duration of response
- measure
- Survival
- measure
- Toxicity as assessed by CTC version 2.0
- measure
- Quality of life as assessed by Schipper's Functional Living Index - Cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic breast cancer
* Bidimensionally measurable lesions
* The following are not considered measurable:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation
* No CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 21 to 75
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2 OR
* Zubrod 0-2
Life expectancy:
* More than 12 weeks
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 11 g/dL
Hepatic:
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* SGOT no greater than 1.25 times ULN
Renal:
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No history of congestive heart failure
* No myocardial infarction within the past 6 months
* No active ischemic heart disease
* No uncontrolled hypertension
Other:
* Not pregnant
* No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix
* No other medical or psychiatric diseases that would preclude study
* No geographical situation that would preclude study
* No history of alcohol abuse
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior adjuvant chemotherapy including ifosfamide or docetaxel
* No prior systemic chemotherapy for metastatic breast cancer
Endocrine therapy:
* See Disease Characteristics
* No concurrent corticoids, gestagens, or androgens unless strictly indicated
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent drinks containing caffeine or alcoholReferences
Publications (0)
Data not yet available
No reference posted for this study.