Trial information
THOR study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Status: Recruiting
Protocol number: ML18742
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to compare progression-free survival in patients with HER2 positive metastatic breast cancer who continue or discontinue Herceptin in combination with 2nd line chemotherapy, having progressed on 1st line chemotherapy in combination with Herceptin
Brief summary: This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 300.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: trastuzumab [Herceptin]
Primary outcome: 1. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Response rate, overall survival Time frame: Event driven
2. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- female patients, >=18 years of age;
- metastatic breast cancer;
- HER2 overexpression (IHC 3+ and/or FISH positive);
- disease progression during or after previous 1st line chemotherapy plus Herceptin;
- scheduled to receive 2nd line chemotherapy.
Exclusion criteria:
- incompatibility with previous Herceptin therapy;
- pregnancy.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/19/2007
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Italy
- Avellino
- Brescia
- Candiolo
- Carrara
- Cosenza
- Crotone - Kr
- Fano
- Ferrara
- Firenze
- Frattaminore
- Genova
- Lecce
- Livorno
- Mantova
- Napoli
- Nocera Inferiore
- Padova
- Palermo
- Paola
- Pavia
- Perugia
- Pordenone
- Potenza
- Ragusa
- Reggio Calabria
- Rionero in Vulture
- Roma
- Salerno
- San Giovanni Rotondo
- Sassari
- Sora
- Taormina
- Torino
- Udine
- Vecchiazzano
