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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00338286 |
The purpose of this study is to further examine the safety of the study drug when used with standard supportive care (i.e., packed red blood cell [RBC] transfusions) compared to standard supportive care alone when used to treat anemia associated with chemotherapy. This study will be done in patients with metastatic breast cancer who are being treated with standard chemotherapy.
Condition | Intervention | Phase |
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Neoplasm Metastasis Breast Cancer |
Drug: epoetin alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Multicenter, Phase 3 Study of Epoetin Alfa Versus Standard Supportive Care in Anemic Subjects With Metastatic Breast Cancer Receiving First-Line Standard Chemotherapy |
Estimated Enrollment: | 1000 |
Study Start Date: | November 2005 |
Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself. This is a randomized, open-label, multicenter, international study to further examine the safety of the study drug used with standard supportive care (i.e., packed RBC transfusions) compared to standard supportive care alone, when used to treat anemia associated with chemotherapy. This study will be done in subjects with metastatic breast cancer who are being or will be treated with first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the risk of tumor progression or death. The study treatment will be compared to the control treatment by comparing progression-free survival, i.e., the number of months from the date a patient is randomized into the trial to the date of the first documented disease progression or death. In addition to their chemotherapy, half of the subjects will be assigned to receive study drug (epoetin alfa) and half of the subjects will be assigned to standard supportive care for anemia.
Subjects treated with the study drug will receive standard supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR005143 |
Study First Received: | June 16, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00338286 |
Health Authority: | United States: Food and Drug Administration |
colony stimulating factor metastatic breast cancer erythropoetin receptor agonist (ERA) gynecologic cancer anemia |
Epoetin Alfa Skin Diseases Anemia |
Neoplasm Metastasis Breast Neoplasms Breast Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |