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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00448279
First received: March 15, 2007
Last updated: October 21, 2014
Last verified: October 2014
  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
Drug: 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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Baseline (BL) and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.

  • Progression-Free Survival - Time to Event [ Time Frame: BL and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.


Secondary Outcome Measures:
  • Overall Survival (OS) - Percentage of Participants With an Event [ Time Frame: BL and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.

  • Overall Survival - Time to Event [ Time Frame: BL and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.

  • Percentage of Participants by Best Overall Response (BOR) [ Time Frame: BL and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  • Percentage of Participants With a Best Overall Response of CR or PR [ Time Frame: BL and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.


Enrollment: 58
Study Start Date: April 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy Alone
Chemotherapy, schedule and dose at the investigator's discretion.
Drug: Chemotherapy
Schedule and dose at the investigator's discretion
Experimental: Chemotherapy, Trastuzumab
Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.
Drug: trastuzumab
2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
Other Name: Herceptin
Drug: Chemotherapy
Schedule and dose at the investigator's discretion

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cona (Ferrara), Italy, 44124
Cosenza, Italy, 87100
Crotone - Kr, Italy, 88900
Fano, Italy, 61032
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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00448279     History of Changes
Other Study ID Numbers: ML18742
Study First Received: March 15, 2007
Results First Received: October 21, 2014
Last Updated: October 21, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014