THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
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
1 other identifier
interventional
58
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Apr 2007
Shorter than P25 for phase_3 breast-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2007
CompletedFirst Posted
Study publicly available on registry
March 16, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
October 24, 2014
CompletedOctober 24, 2014
October 1, 2014
3.4 years
March 15, 2007
October 21, 2014
October 21, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) - Percentage of Participants With an Event
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.
Baseline (BL) and every 8 weeks thereafter
Progression-Free Survival - Time to Event
The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.
BL and every 8 weeks thereafter
Secondary Outcomes (4)
Overall Survival (OS) - Percentage of Participants With an Event
BL and every 8 weeks thereafter
Overall Survival - Time to Event
BL and every 8 weeks thereafter
Percentage of Participants by Best Overall Response (BOR)
BL and every 8 weeks thereafter
Percentage of Participants With a Best Overall Response of CR or PR
BL and every 8 weeks thereafter
Study Arms (2)
Chemotherapy Alone
ACTIVE COMPARATORChemotherapy, schedule and dose at the investigator's discretion.
Chemotherapy, Trastuzumab
EXPERIMENTALTrastuzumab, 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.
Interventions
2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
Schedule and dose at the investigator's discretion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- incompatibility with previous Herceptin therapy;
- pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Avellino, 83100, Italy
Unknown Facility
Brescia, 25123, Italy
Unknown Facility
Candiolo, 10060, Italy
Unknown Facility
Carrara, 54033, Italy
Unknown Facility
Cona (Ferrara), 44124, Italy
Unknown Facility
Cosenza, 87100, Italy
Unknown Facility
Crotone - Kr, 88900, Italy
Unknown Facility
Fano, 61032, Italy
Unknown Facility
Florence, 50139, Italy
Unknown Facility
Frattaminore, 80026, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Lecce, 73100, Italy
Unknown Facility
Livorno, 57100, Italy
Unknown Facility
Mantova, 46100, Italy
Unknown Facility
Meldola, 47014, Italy
Unknown Facility
Napoli, 80131, Italy
Unknown Facility
Nocera Inferiore, 84014, Italy
Unknown Facility
Padua, 35128, Italy
Unknown Facility
Palermo, 90127, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Perugia, 06122, Italy
Unknown Facility
Pordenone, 33170, Italy
Unknown Facility
Potenza, 85100, Italy
Unknown Facility
Ragusa, 97100, Italy
Unknown Facility
Reggio Calabria, 89100, Italy
Unknown Facility
Rionero in Vulture, 85028, Italy
Unknown Facility
Roma, 00128, Italy
Unknown Facility
Roma, 00153, Italy
Unknown Facility
Salerno, 84131, Italy
Unknown Facility
San Giovanni Rotondo, 71013, Italy
Unknown Facility
Sassari, 07100, Italy
Unknown Facility
Sora, 03039, Italy
Unknown Facility
Taormina, 98030, Italy
Unknown Facility
Torino, 10125, Italy
Unknown Facility
Udine, 33100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2007
First Posted
March 16, 2007
Study Start
April 1, 2007
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
October 24, 2014
Results First Posted
October 24, 2014
Record last verified: 2014-10