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A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Neoplasm Metastasis

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Trial Information

A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy


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.The hypothesis is to test that epoetin alfa, when used as supportive
anemia care, is non-inferior to control (standard supportive care alone), as measured by
progression free survival (PFS). Patients treated with the study drug will receive standard
supportive care (packed red blood cells (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. Dose adjustments (dose escalation, dose
reduction, dose interruption, and dose resumption) of epoetin alfa will be based on
hemoglobin (Hb) and confirm to prescribing information.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival, measured in months from the date of randomization to the date of the first documented disease progression or death, whichever comes first.

Outcome Time Frame:

When approximately 1650 PFS events are available

Safety Issue:

Yes

Principal Investigator

Janssen Research & Development, LLC C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

United States: Food and Drug Administration

Study ID:

CR005143

NCT ID:

NCT00338286

Start Date:

March 2006

Completion Date:

June 2017

Related Keywords:

  • Breast Cancer
  • Neoplasm Metastasis
  • anemia
  • metastatic breast cancer
  • Hemoglobin
  • progression-free survival (PFS)
  • erythropoiesis-stimulating agents (ESA)
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Louisville, Kentucky  40207
Scarborough, Maine  04074
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Boston, Massachusetts  
Charleston, South Carolina  
Jackson, Mississippi