Trial information
A PK-Loading Study of q3w Herceptin (Trastuzumab) Monotherapy in Women With HER2 Positive Metastatic Breast Cancer.
Status: Completed
Protocol number: MO16982
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Brief summary: This study will evaluate a new loading schedule of Herceptin (6mg/kg iv weekly for 3 weeks) followed by a maintenance regimen (6mg/kg iv every 3 weeks). Blood samples will be taken for pharmacokinetic analysis, and tumor response and progression will be measured. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is
70.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Pharmacokinetics study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: trastuzumab[Herceptin]
Primary outcome: 1. Safety and tolerability of the loading regimen; pharmacokinetics of the loading regimen
Key secondary outcomes: 1. Pharmacokinetics:Steady state concentration of Herceptin; Efficacy:Response rate; time to disease progression
Inclusion criteria:
- female patients, >=18 years of age;
- metastatic breast cancer;
- HER2 overexpression (IHC3+ and/or FISH positive);
- ECOG 0-2.
Exclusion criteria:
- >1 prior chemotherapy regimen for advanced/metastatic disease;
- prior treatment with anti-HER therapies;
- clinically significant cardiovascular disease.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/19/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Toronto, ON
- Greenfield Park, QC
United Kingdom
