Status:
COMPLETED
Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer
Lead Sponsor:
ARCAGY/ GINECO GROUP
Conditions:
Breast Cancer
Eligibility:
FEMALE
70+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividi...
Detailed Description
OBJECTIVES: Primary * Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer. Secondary * ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive ductal or lobular adenocarcinoma of the breast
- Metastatic disease as confirmed by ≥ 1 of the following:
- Histology or cytology
- Radiology
- Elevated CA 15-3 levels
- No HER2/neu overexpression by IHC or FISH
- Measurable (≥ 10 mm) or evaluable disease
- Bone lesions or isolated pleural effusion allowed
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Postmenopausal
- Life expectancy \> 3 months
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Alkaline phosphatase ≤ 5 times ULN
- Bilirubin ≤ 2 times ULN
- Creatinine clearance ≥ 30 mL/min
- LVEF ≥ 50%
- No congestive heart failure or other uncontrolled cardiac disease
- No other malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix, urothelial in situ carcinoma, or basal cell cancer
- No prior hypersensitivity to anthracyclines
- No psychological, familial, social, or geographical reason that would preclude study follow-up
- No serious illness or physical or mental condition resulting in a permanent disability that may preclude successful treatment
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
- Prior adjuvant chemotherapy allowed
- No development of metastatic disease within 6 months after completion of adjuvant anthracycline-based chemotherapy
- No more than 300 mg/m² of prior doxorubicin hydrochloride or 600 mg/m² of prior epirubicin hydrochloride in the adjuvant setting
- More than 30 days since prior participation in another clinical trial
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00960336
Start Date
March 1 2008
Last Update
October 29 2014
Active Locations (1)
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1
Hotel Dieu de Paris
Paris, France, 75181