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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00448279
First received: March 15, 2007
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: trastuzumab [Herceptin]
Drug: Second line chemotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate, overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: November 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab [Herceptin]
2mg/kg iv weekly, or 6mg/kg every 3 weeks
Drug: Second line chemotherapy
As prescribed
Active Comparator: 2 Drug: Second line chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448279

Locations
Italy
Avellino, Italy, 83100
Brescia, Italy, 25123
Candiolo, Italy, 10060
Carrara, Italy, 54033
Cosenza, Italy, 87100
Crotone - Kr, Italy, 88900
Fano, Italy, 61032
Ferrara, Italy, 44100
Firenze, Italy, 50139
Frattaminore, Italy, 80026
Genova, Italy, 16132
Lecce, Italy, 73100
Livorno, Italy, 57100
Mantova, Italy, 46100
Meldola, Italy, 47014
Napoli, Italy, 80131
Nocera Inferiore, Italy, 84014
Padova, Italy, 35128
Palermo, Italy, 90127
Pavia, Italy, 27100
Perugia, Italy, 06122
Pordenone, Italy, 33170
Potenza, Italy, 85100
Ragusa, Italy, 97100
Reggio Calabria, Italy, 89100
Rionero in Vulture, Italy, 85028
Roma, Italy, 00153
Roma, Italy, 00128
Salerno, Italy, 84131
San Giovanni Rotondo, Italy, 71013
Sassari, Italy, 07100
Sora, Italy, 03039
Taormina, Italy, 98030
Torino, Italy, 10125
Udine, Italy, 33100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00448279     History of Changes
Other Study ID Numbers: ML18742
Study First Received: March 15, 2007
Last Updated: February 15, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013