A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy
November 29, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex (Epoetin Alfa) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy
The purpose of this study is to evaluate the impact on survival and quality of life of maintaining hemoglobin in the range of 12 to 14 g/dL using epoetin alfa or placebo in patients starting chemotherapy for metastatic breast cancer for the first time.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cancer patients often experience anemia due to the disease itself, chemotherapy or both.
Quality of life is also affected, due in part to the fatigue associated with anemia.
Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer.This randomized, double-blind, placebo-controlled multi-center study evaluated the effects of treatment with epoetin alfa in maintaining hemoglobin levels between 12 and 14 g/dL to determine its impact on survival and quality of life, in addition to investigating the possible role that epoetin alfa may have on tumor response to chemotherapy.
During the double-blind portion of the study, patients were to receive 12 months of treatment with epoetin alfa or placebo.
Thereafter, follow-up evaluations were to occur every 3 months until 75% of the patients had died.
Effectiveness was to be determined by recording the number of patients surviving at 12 months, the change in hemoglobin from the start of the study until study completion, response to chemotherapy and quality of life.
Safety evaluations (incidence of adverse events, physical examinations and clinical laboratory tests) were to be performed throughout the study.
The study hypothesis was that maintaining hemoglobin in the range of 12 to 14 g/dL would improve 12-month survival and quality of life in patients with metastatic breast cancer who were receiving chemotherapy.
Since the time this study was originally designed, the prescribing information for epoetin alfa has changed.
Current use of epoetin alfa should follow the prescribing information.
Patients were to receive epoetin alfa injections (40,000 units) under their skin once per week for 12 months or matching placebo.
Dosage was to be adjusted up (to 60,000 units) or down (to 75% of the last dose administered) as needed to maintain hemoglobin levels between 12 and 14 g/dL.
Study Type
Interventional
Enrollment (Actual)
939
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female patients >= 18 years of age with confirmed diagnosis of metastatic breast cancer who are predicted to start chemotherapy for the first time
- Weight > = 40 kg (88 lbs)
- Postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control and have a negative serum pregnancy test at the start of the study
- Must have signed an informed consent
Exclusion Criteria:
- Clinically significant lung, heart, hormone, neurological, gastrointestinal, urinary tract or reproductive system disease
- Receiving dose intensification chemotherapy for bone marrow or stem cell transplantation
- Cancer of the brain or brain/spinal cord disease
- Locally advanced or inflammatory breast cancer as the only symptom of breast cancer
- Active second primary cancer or documented history of other cancer within the last 3 years
- Anemia from a cause other than cancer or radiotherapy/chemotherapy
- History of stoke, clots in the lungs or legs or any other blood clotting disorders
- Uncontrolled high blood pressure
- Untreated folate or Vitamin B12 deficiency
- Treatment with epoetin alfa or other forms of erythropoietin within the last 4 weeks
- Known hypersensitivity to epoetin alfa or any of its components
- Pregnant or breast-feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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12-month survival rate, defined as the proportion of patients alive at 12 months after the start of the study.
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Secondary Outcome Measures
Outcome Measure |
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Hemoglobin and change in hemoglobin. End of chemotherapy/end of study tumor response. Quality of life. Overall 12-month survival. Red blood cell transfusion rates. Time-to-cancer progression. Overall/median survival times.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2000
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
November 30, 2010
Last Update Submitted That Met QC Criteria
November 29, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004414
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