Clinical trial NCT00448279: THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-16
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Baseline (BL) and every 8 weeks thereafter
measure: Progression-Free Survival - Time to Event
timeFrame: BL and every 8 weeks thereafter
Secondary outcomes:
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: BL and every 8 weeks thereafter
measure: Overall Survival - Time to Event
timeFrame: BL and every 8 weeks thereafter
measure: Percentage of Participants by Best Overall Response (BOR)
timeFrame: BL and every 8 weeks thereafter
measure: Percentage of Participants With a Best Overall Response of CR or PR
timeFrame: BL and every 8 weeks thereafter
Other outcomes:
Locations:
city: Avellino
country: Italy
city: Brescia
country: Italy
city: Candiolo
country: Italy
city: Carrara
country: Italy
city: Cona (Ferrara)
country: Italy
city: Cosenza
country: Italy
city: Crotone - Kr
country: Italy
city: Fano
country: Italy
city: Firenze
country: Italy
city: Frattaminore
country: Italy
city: Genova
country: Italy
city: Lecce
country: Italy
city: Livorno
country: Italy
city: Mantova
country: Italy
city: Meldola
country: Italy
city: Napoli
country: Italy
city: Nocera Inferiore
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Pordenone
country: Italy
city: Potenza
country: Italy
city: Ragusa
country: Italy
city: Reggio Calabria
country: Italy
city: Rionero in Vulture
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Salerno
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Sassari
country: Italy
city: Sora
country: Italy
city: Taormina
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: