Study Complete
Sponsor ID
20010144

Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

Sponsor ID
20010144
Clinicaltrials.gov ID
NCT00035594
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.

Additional Study Details

Phase
Phase 3
Product
pegfilgrastim
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
928
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of subjects developing febrile neutropenia

Timeframe: Through 4 cycles

Secondary Outcome Measures

Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time

Timeframe: Through 4 cycles

Locations

No locations found.