Clinical trial · Interventional
S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer
Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)
NCT00025493CI-TRIAL-00009122terminatedPhase 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): poor accrual
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 in treating older 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel
- description
- docetaxel
- interventionNames
- Drug: docetaxel
Primary outcomes (1)
- measure
- Study treatment feasibility
- timeFrame
- monthly for duration of accrual
Secondary outcomes (6)
- measure
- Overall survival
- timeFrame
- at weeks 10 and 19, then every 3 months for 3 years
- measure
- Survival at 2 years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Distant metastatic disease confirmed by histology, cytology, or strong clinical evidence * Measurable disease * No known brain or CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 70 and over OR * Under 60 Sex: * Female Menopausal status: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Hemoglobin at least 9 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT or SGPT no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present) * Alkaline phosphatase no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present) Renal: * Creatinine no greater than ULN Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy for breast cancer Chemotherapy: * Prior adjuvant or neoadjuvant chemotherapy allowed * Prior adjuvant taxanes allowed * No other concurrent chemotherapy for breast cancer Endocrine therapy: * Prior hormonal therapy in the adjuvant setting or for metastatic disease allowed * No concurrent hormonal therapy for breast cancer Radiotherapy: * No concurrent radiotherapy for breast cancer Surgery: * Not specified Other * No more than 1 prior regimen for advanced, recurrent, or metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.