SPROG

A prospective randomised comparison of G-CSF (filgrastim) secondary prophylaxis versus conservative management of chemotherapy induced neutropenia to maintain dose intensity in chemotherapy for breast cancer.

Objectives

Primary:

• To determine the impact of G-CSF secondary prophylaxis on the delivered dose-intensity of chemotherapy for early breast cancer by assessing the proportion of patients achieving greater or equal to 85% of planned dose intensity in each arm.
  
  
• To determine the proportion of patients who experience at least one neutropenic event following randomisation in each arm.

Secondary:

• To compare the dose intensity achieved in each arm.
  
  
• To assess the cost of management.

Accrual: 384 patients recruited as of 23rd November 2006.

• Figure 1 shows cumulative monthly recruitment for 2002.
  
  
  Figure 2 shows cumulative monthly recruitment for 2003.
  
  
• Figure 3 shows cumulative monthly recruitment for 2004.

Trial closing date: Quarter 1, 2007

Main contact: Michelle McLinden

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