Clinical trial · Interventional
Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
NCT00003540CI-TRIAL-00011124completedPhase 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 gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.
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 |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
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 bone scan abnormalities alone * Lytic lesions in conjunction with bone scan abnormalities allowed * No pure blastic bone metastases * No pleural or peritoneal effusions * No previously irradiated lesions * Must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer * Brain metastases allowed if other measurable disease exists * No uncontrolled or life threatening brain lesions * No carcinomatous meningitis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * AST/ALT no greater than 5 times upper limit of normal Renal: * Calcium no greater than 11.0 mg/dL Other: * Not pregnant * Negative pregnancy test * No history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer * No other serious medical illnesses, including severe infection and severe malnutrition PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * Prior hormonal therapies for stage IV disease and/or adjuvant therapy allowed * At least 3 weeks since prior hormonal therapy Radiotherapy: * See Disease Characteristics * No prior radiotherapy to greater than 30% of the marrow bearing bone * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy to the only measurable lesion Surgery: * Recovered from prior surgery * No concurrent surgery to the only measurable lesion Other: * No concurrent nonprotocol treatment
References
Publications (0)
Data not yet available
No reference posted for this study.