A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

Completed · Phase 3

Conditions studied: Breast Cancer, Neoplasm Metastasis

In brief

The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.

Key facts

Study ID

NCT00338286

Run by

Janssen Research & Development, LLC

People needed

2098

Starts

2006-03-02

Expected to finish

2017-01-31

Last updated by the study team

2018-03-19

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed (e.g., slide of tissue) breast cancer
• HER2/NEU positive or negative
• Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy
• Received 1st and 2nd line chemotherapy
• Hemoglobin (Hb) <= 11g/dL at the time of randomization
• planned to receive at least 2 more cycles of chemotherapy
• Life expectancy > 6 months
• Eastern Cooperative Oncology Group score 0 or 1
• At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year

You may not qualify if…

• Active second cancer
• no recent history of clinically relevant thrombovascular event
• Current treatment with anticoagulants
• Brain metastasis or CNS involvement
• Anemia secondary to another cause
• Recent (within prior 1 months) use of an ESA
• Patient pregnant or breast feeding
• Progressive disease during adjuvant/neoadjuvant chemotherapy
• Rapidly progressive or life-threatening metastatic disease
• Concomitant endocrine therapy
• Patient in whom the only site of metastasis was local and was successfully treated surgically.

Where it is running

• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Rockledge, Florida, United States
• Study site — Hazard, Kentucky, United States
• Study site — Alexandria, Louisiana, United States
• Study site — Marrero, Louisiana, United States
• Study site — Jackson, Mississippi, United States
• Study site — Lake Success, New York, United States
• Study site — Staten Island, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Corpus Christi, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Capital Federal, Argentina
• Study site — Ciudad Autonoma de Buenos Airess, Argentina
• Study site — Córdoba, Argentina
• Study site — La Plata, Argentina
• Study site — Mendoza, Argentina
• Study site — Quilmes, Argentina
• Study site — Rosario, Argentina
• Study site — Santa Fe, Argentina
• Study site — Barretos, Brazil
• Study site — Curitiba, Brazil
• Study site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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