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Breast

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex? (Epoetin Alfa; RWJPRI-22512) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy

Unique Data Set IDBreast_Johnson_2000_125
DownloadableYes
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Data ProviderJanssenTotal Study Enrolled Patients939Comparator (Control) Arm Enrolled Patients470RandomizationYesClinicalTrial.gov IDN/AClinicalTrial.gov URLN/A
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeOther

Clinical Trial Title

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex? (Epoetin Alfa; RWJPRI-22512) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy

Trial Summary and Conditions

This was a Phase 3, double-blind, randomized, placebo-controlled, multicenter trial to evaluate the impact of maintaining Hb in the range of 12 to 14 g/dL using epoetin alfa in subjects with metastatic breast cancer who were receiving chemotherapy. A total of 939 subjects were enrolled in the study from 139 sites in 20 countries in Europe, Canada, South Africa, and Australia. Subjects were randomly assigned to receive either 40,000 IU epoetin alfa or placebo in a 1:1 ratio. Randomization was stratified by metastatic category (bone metastasis only versus other measurable metastatic lesions versus other non-measurable metastatic lesions) to ensure balance in the epoetin alfa and placebo arms. . Study drug was administered once a week by subcutaneous. injection to maintain Hb in the range of 12 to 14 g/dL for 12 months. Subjects could undergo a red blood cell (RBC) transfusion if clinically necessary during the study. Subjects who met the entry criteria were randomized, and study drug was administered when Hb was 13 g/dL or lower. Hemoglobin concentrations and reticulocyte counts were monitored weekly for the first 4 weeks of the study to determine either when study drug administration was to begin or whether a dose adjustment was necessary. After the first 4 weeks of study drug administration, Hb concentrations and reticulocyte counts were monitored every 3 to 4 weeks for the remainder of the double-blind treatment phase. The maximum dose of epoetin alfa was not to exceed 60,000 IU once a week. After subjects had been on the study for 12 months, they completed the double-blind phase of the study and had the option of receiving 40,000 IU epoetin alfa once a week to maintain Hb in the range of 12 to 14 g/dL in an open-label extension. During the open-label extension, Hb concentrations and reticulocyte counts were monitored frequently and survival reports were submitted every 6 months until death.

Data Summary

Control arm (Placebo) data files include raw data on safety, efficacy, demographic, and baseline disease characteristics.

Study Objectives

The objective of this study was to evaluate the impact on survival and quality of life (QoL) of maintaining hemoglobin (Hb) in the range of 12 to 14 g/dL using epoetin alfa or placebo in subjects starting first-line chemotherapy for metastatic breast carcinoma.

Outcome Measures

The primary efficacy endpoint for the double-blind phase of the study was 12-month survival, defined as the proportion of subjects surviving at 12 months after randomization. Secondary efficacy endpoints were change in Hb concentration from baseline to individual study end, Hb concentration over time, optimal tumor response to first-line chemotherapy, tumor response at the end of first-line chemotherapy, tumor response at the end of the study, time to disease progression, proportion of subjects receiving RBC transfusions from baseline to study end, standardized cumulative RBC units transfused from baseline to study end, and QoL as measured by the Functional Assessment of Cancer Therapy-Anemia Scale (FACT-An) and Cancer Linear Analog Scale (CLAS).

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: EPO-INT-76-Protocol.pdf

CRF: EPO-INT-76-blankcrf.pdf

DATA DICTIONARY: EPO-INT-76_contents.xls

DATA (COMPARATOR ARM): EPO-INT-76-Datasets.zip