Trial information
A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Status: Recruiting
Protocol number: ML19944
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to compare time to disease progression 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 (6mg/kg iv infusion every 3 weeks) while receiving second-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
274.
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. Time to disease progression Time frame: Event driven
Key secondary outcomes: 1. Objective response rate, clinical benefit, time to treatment failure, overall survival. Time frame: Event driven
2. AEs, laboratory parameters, LVEF. 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 + Herceptin;
- scheduled to receive 2nd line chemotherapy.
Exclusion criteria:
- concurrent immunotherapy or hormonal therapy;
- anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
- cardiac toxicity during previous 1st line chemotherapy + Herceptin;
- history of other malignancy within last 5 years.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2007
Trial registration date: 10/17/2006
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Bulgaria
- Plovdiv
- Sofia
- Veliko Tarnovo
Estonia
Hungary
- Budapest
- Debrecen
- Gyor
- Gyula
- Nyiregyhaza
- Pecs
- Szeged
- Szekesfehervar
- Szombathely
- Zalaegerszeg
Israel
- Beer Sheva
- Haifa
- Holon
- Jerusalem
- Kfar Saba
- Petah Tikva
- Ramat Gan
- Rehovot
- Safed
- Tel Aviv
- Zerifin
Lithuania
Macedonia, The Former Yugoslav Republic of
Romania
Slovakia
Turkey
- Adana
- Ankara
- Bursa
- Istanbul
