Clinical trial · Interventional
Docetaxel in Treating Older Women With Metastatic Breast Cancer
Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70
NCT00104624CI-TRIAL-00011980terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Toxicity issues
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.
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 |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
Secondary outcomes (6)
- measure
- Response rate
- measure
- Overall survival
- measure
- Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
- measure
- Progression-free survival
- measure
- Mood status as measured by the Geriatric Depression Scale
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease * Measurable disease by CT scan or MRI * Requires first-line chemotherapy for metastatic disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 70 and over Sex * Female Menopausal status * Not specified Performance status * Meets both of the following criteria: * Lawton's Instrumental Activities of Daily Living score ≥ 4 * Katz's Activities of Daily Living score ≥ 4 Life expectancy * More than 3 months Hematopoietic * Hemoglobin \> 10 g/dL * Neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * ALT and AST \< 1.5 times normal * Bilirubin normal * Alkaline phosphatase \< 2.5 times normal Renal * Creatinine clearance \> 30 mL/min Cardiovascular * No congestive heart failure * No unstable angina pectoris * No myocardial infarction within the past year * No uncontrolled hypertension * No high-risk uncontrolled arrhythmias Other * Geriatric Depression Score \< 12 * No active uncontrolled infection * No active peptic ulcer * No uncontrolled diabetes mellitus * No inflammatory bowel disease * No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80 * No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent * No familial, social, geographical, or psychological condition that would preclude study follow-up * No definite contraindication to corticosteroids * No other serious illness or medical condition * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior or concurrent trastuzumab (Herceptin\^®) Chemotherapy * Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed * More than 2 years since prior docetaxel or paclitaxel * No other concurrent chemotherapy Endocrine therapy * No more than 1 prior hormonal therapy regimen for metastatic disease * At least 10 days since prior hormonal therapy * No concurrent hormonal therapy * No concurrent chronic corticosteroids * Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated \> 6 months before study entry Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior active treatment on another clinical trial * Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia * No other concurrent anticancer therapy * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.