Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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 dividing. PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.

Detailed Description
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OBJECTIVES: Primary Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer. Secondary Determine the feasibility of this drug in these patients. Evaluate chemotherapy-induced toxicities in these patients. Assess the disease-free survival and overall survival of these patients. Study the geriatric covariates. Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients. OUTLINE: This is a multicenter study. Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or progressive disease. After completion of study therapy, patients are followed up periodically for 2 years.

Official Title
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Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br> | Drug: pegylated liposomal doxorubicin hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 3 and 6 cures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2-negative breast cancer, recurrent breast cancer, stage IV breast cancer, invasive ductal breast carcinoma, invasive lobular breast carcinoma