Phase 3
Completed N=58
THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Source: ClinicalTrials.gov NCT00448279 ↗Enrolled (actual)
58
Serious AEs
9.3%
Results posted
Oct 2014
Primary outcomePrimary: Progression-Free Survival (PFS) - Percentage of Participants With an Event — 58.6; 58.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) - Percentage of Participants With an Event |
58.6; 58.6 | — |
| PRIMARY Progression-Free Survival - Time to Event |
9.7; 9.4 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
55.2; 34.5 | — |
| SECONDARY Overall Survival - Time to Event |
19.1; 26.7 | — |
| SECONDARY Percentage of Participants by Best Overall Response (BOR) |
0; 10.3; 27.6; 20.7; 24.1; 24.1 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of CR or PR |
27.6; 31.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00448279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.