Trial information
An Expanded Access Program of Neulastim (Pegfilgrastim) in Patients With Breast Cancer
Status: Completed
Protocol number: ML19813
Sponsor: Grupo Roche Syntex de Mexico
Company division: Pharmaceutical
Official Scientific Title: An expanded access program to evaluate the effect of Neulastim on CT dose intensity and neutropenia-related events in patients receiving chemotherapy for breast cancer.
Brief summary: This study will assess the prophylactic effect of Neulastim on the intensity of chemotherapy dose, and intensity and duration of neutropenia, in patients receiving taxane- or anthracycline-based chemotherapy for breast cancer. Neulastim will be administered at a fixed dose of 6mg sc 24 hours after the end of each treatment cycle.The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
120.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: pegfilgrastim[Neulastim]
Primary outcome: 1. Proportion of patients who receive >= 85% of intensity of chemotherapeutic dose
Key secondary outcomes: 1. Efficacy: Duration of neutropenia; % of patients with febrile neutropenia. Safety: AEs, laboratory tests
Inclusion criteria:
- female patients, 18-70 years of age;
- candidates for taxane- or anthracycline-based chemotherapy;
- ECOG 0-2;
- >=4 chemotherapy cycles planned.
Exclusion criteria:
- patients receiving neulastim or other GFSs within 21 days of study start;
- weekly chemotherapy schedule;
- radiotherapy within 30 days of study start;
- bone marrow diseases;
- previous allergic reactions to GSFs or other E. coli products;
- active infections requiring use of antibiotics within 7 days of study start.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/16/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Colombia
Mexico
- Chihuahua
- Mexico City
- Monterrey
- Puebla
- Tijuana
- Toluca
