Management of Metastatic Breast Cancer in Frail Patients

Study Overview
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Brief Summary
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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 elderly women who have metastatic breast cancer.

Detailed Description
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OBJECTIVES: I. Determine the safety and efficacy of gemcitabine in the treatment of elderly women with metastatic breast cancer. II. Evaluate the quality of life in these patients. OUTLINE: Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8 week course. Treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 12 weeks. Patients are followed every 3 months for 2 years, then every 6 months until year 5, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.

Official Title
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Management of Metastatic Breast Cancer in Frail Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Metastatic breast cancer Measurable disease No progression after 3 or more different forms of chemotherapy Hormone receptor positive breast cancer must be refractory to at least two forms of hormonal treatment (including antiestrogen, aromatase inhibitor, and/or progestin) unless there is life threatening metastases (e.g., lymphangitic metastases to the lung or liver metastases) Must meet at least one of the following characteristics for frailty: ECOG 2-4 Dependence in at least one activity of daily living 85 and over History of three or more falls in the past 6 months Mild dementia (must be oriented in time, space, and location) Three or more comorbid conditions Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 65 and over Sex: Female Menopausal status: Not specified Performance status: See Disease Characteristics Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Neutropenia or thrombocytopenia secondary to myelophthisis from breast cancer allowed Hepatic: Increased bilirubin allowed Renal: Renal insufficiency allowed Cardiovascular: Congestive heart failure allowed Other: No known allergy to gemcitabine PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy to bony areas or CNS metastases Surgery: Not specified Other: Concurrent bisphosphonates allowed No concurrent participation in other investigational studies

Ages Eligible for Study
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Minimum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine Treatment<br>Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8 week course. Treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 12 weeks. Patients are followed every 3 months for 2 years, then every 6 months until year 5, and then annually thereafter. | Drug: Gemcitabine hydrochloride<br>* Gemcitabine via IV<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Investigators planned to determine efficacy (objective response rate [ORR] by Response Evaluation Criteria In Solid Tumors [RECIST]). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | Investigators planned to review adverse events utilizing Common Toxicity Criteria (CTC) V3. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer