NCT00211133

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
939

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

First QC Date

September 13, 2005

Last Update Submit

November 29, 2010

Conditions

AnemiaBreast NeoplasmsQuality of Life

Keywords

AnemiaBreast CancerBreast TumorQuality of LifeWomenFemaleChemotherapyHemoglobinSurvivalEpoetinEpoetin alfaerythropoietin

Outcome Measures

Primary Outcomes (1)

  • 12-month survival rate, defined as the proportion of patients alive at 12 months after the start of the study.

Secondary Outcomes (1)

  • 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.

Interventions

epoetin alfaDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Leyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G, Makhson A, Roth A, Dodwell D, Baselga J, Biakhov M, Valuckas K, Voznyi E, Liu X, Vercammen E. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J Clin Oncol. 2005 Sep 1;23(25):5960-72. doi: 10.1200/JCO.2005.06.150. Epub 2005 Aug 8.

    PMID: 16087945RESULT

MeSH Terms

Conditions

AnemiaBreast Neoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2000

Study Completion

December 1, 2006

Last Updated

November 30, 2010

Record last verified: 2010-11