Clinical Trial Result Information

Protocol number
ML18028

Title of Study
An open-label study to investigate the efficacy and safety of epoetin beta 30 000 IU once weekly in anemic patients with metastatic breast cancer.

Sponsor
Roche farmacevtska druzba d.o.o.

Company division
Pharmaceutical

Product name
NeoRecormon

Generic name
epoetin beta

Therapeutic area
Anemia

Clinical study summary
This was an open-label, one-arm, single-center study to assess the safety and efficacy of weekly administration of NeoRecormon (epoetin beta) using the 30 000 IU pre-filled syringe in anemic patients with metastatic breast cancer.

Study center(s)
1 center in Slovenia.

Phase of development
II

Objectives
To assess the safety of once-weekly administration of NeoRecormon using the 30 000 IU pre-filled syringe in anemic patients with metastatic breast cancer.

Methodology
Patients with metastatic breast cancer and anemia were treated after a screening period of 2 weeks with weekly injections of subcutaneous NeoRecormon 30 000 IU, by pre-filled syringe, for 16 weeks. Every 4 weeks during the study blood pressure, heart rate, hemoglobin, hematocrit, platelets, reticulocytes, serum iron, ferritin and transferrin were measured.

Number of patients (planned/analyzed)
Planned: 10. Enrolled: 13.

Diagnosis and main criteria for inclusion
Adult patients with histologically confirmed diagnosis of metastatic breast cancer and hemoglobin (Hb) ≤11 g/dL at screening visit.

Test product, dose and mode of administration or test procedure
NeoRecormon (epoetin beta) 30 000 IU / subcutaneous / once weekly.

Duration of treatment
16 weeks

Reference therapy, dose and mode of administration or reference procedure
N/A

Criteria for evaluation (efficacy, safety)
Efficacy: Hemoglobin, hematocrit, serum iron level, ferritin and transferrin level.
Safety: AEs, SAEs and deaths. Vital signs.

Statistical methods
A 2-sided t-test was used to determine efficacy. Descriptive statistics were used to analyze the incidence of adverse events during the study period.

Summary (efficacy, safety, other results)
Efficacy: There were significant increases in mean Hb from baseline level (9.95 ± 0.70 g/dL) to week 4 (10.81 ± 1.44 g/dL; p=0.024) and week 16 (12.31 ± 2.04 g/dL; p=0.008). The mean increase in Hb level in 8 patients who completed the 16-week study was 2.36 ± 1.82 g/dL. One of 8 patients (13%) who completed the study did not respond to treatment, and received a red blood cell transfusion.

Safety: 3 out of 11 patients terminated the study before week 16. The reasons for withdrawal were death from bilateral pulmonary thromboembolism after breast surgery (1 patient), disease progression (1 patient), and inadequate response to NeoRecormon with abnormal serum iron values (1 patient).

Conclusions
In this study, NeoRecormon was shown to be effective in correcting anemia; the results show a significant increase in hemoglobin level. The study provided experience with a once weekly regimen and showed that NeoRecormon 30 000 IU once weekly subcutaneous was a safe, well tolerated and effective treatment for anemia management in patients with metastatic breast cancer.

Publications (references, if available)
Annals of Oncology 17 (Supplement 9): ix304, 2006: abstract 1058.

Date of report
3/1/2007

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