Clinical trial · Interventional
Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
NCT00027989CI-TRIAL-00013084unknownPhase 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 combining liposomal doxorubicin with gemcitabine 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 |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic breast cancer * Measurable disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * No impaired bone marrow function Hepatic: * Bilirubin no greater than 2 mg/dL * AST and ALT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN (unless attributed to tumor) * No impaired hepatic function Renal: * Creatinine no greater than 2.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No impaired renal function Cardiovascular: * No prior cardiac disease within the past 5 years OR * LVEF at least 50% Other: * No prior uncontrolled seizures * No uncontrolled systemic infection * No anthracycline resistance * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior trastuzumab (Herceptin) Chemotherapy: * Prior adjuvant therapy with anthracycline of no more than 320 mg/m\^2 allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to more than 1/3 of hematopoietic sites Surgery: * Not specified Other: * At least 30 days since prior investigational medications and recovered * No more than 1 prior treatment regimen for metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.