Phase 3
Completed N=602
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
Source: ClinicalTrials.gov NCT01419197 ↗Enrolled (actual)
602
Serious AEs
23.8%
Results posted
May 2014
Primary outcomePrimary: Progression-free Survival — 6.2; 3.3 Months — p=<0.0001
Summary
This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
6.2; 3.3 | <0.0001 sig |
| PRIMARY Overall Survival |
NA; 14.9 | 0.0034 sig |
| SECONDARY Percentage of Participants With an Objective Response |
31.3; 8.6 | <0.0001 sig |
| SECONDARY Duration of the Objective Response |
9.7; NA | — |
| SECONDARY 6-month and 1-year Survival |
90.9; 78.3; 68.6; 56.9 | 0.0011 sig |
| SECONDARY Time to Pain Symptom Progression |
2.9; 3.6 | 0.4952 |
| SECONDARY Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle |
-3.4; -9.4; -4.6; -6.1; -4.8; -3.8 | — |
| SECONDARY Overall Survival (Final Analysis) |
22.7; 15.8 | 0.0007 sig |
| SECONDARY 6-month and 1-year Survival (Final Analysis) |
91.3; 78.9; 76.5; 65.6 | 0.0003 sig |
Eligibility Criteria
Inclusion Criteria
- Adult participants ≥ 18 years of age.
- Histologically or cytologically documented breast cancer.
- Metastatic or unresectable locally advanced/recurrent breast cancer.
- HER2-positive disease by prospective laboratory confirmation.
- Disease progression on the last regimen received as defined by the investigator.
- Prior treatment with an trastuzumab, a taxane, and lapatinib.
- Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
- Adequate organ function, as evidenced by laboratory results.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multi gated acquisition scan.
Exclusion Criteria
- Chemotherapy ≤ 21 days before first study treatment.
- Trastuzumab ≤ 21 days before first study treatment.
- Lapatinib ≤ 14 days before first study treatment.
- Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.
- Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
Data sourced from ClinicalTrials.gov (NCT01419197). 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.