Status:

COMPLETED

THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

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 bre...

Eligibility Criteria

Inclusion

  • 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

  • incompatibility with previous Herceptin therapy;
  • pregnancy.

Key Trial Info

Start Date :

April 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT00448279

Start Date

April 1 2007

End Date

September 1 2010

Last Update

October 24 2014

Active Locations (35)

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Page 1 of 9 (35 locations)

1

Avellino, Italy, 83100

2

Brescia, Italy, 25123

3

Candiolo, Italy, 10060

4

Carrara, Italy, 54033