Phase 3
N=8,381
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Neoplasms, Breast
Bottom Line
View on ClinicalTrials.gov: NCT00490139 ↗Enrolled (actual)
8,381
Serious AEs
16.0%
Results posted
Aug 2014
Primary outcome: Primary: Disease-Free Survival (DFS) at the Primary Analysis — 1.9; 1.3; 1.0; 1.5 Years — p=0.048
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lapatinib (Drug); Trastuzumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-Free Survival (DFS) at the Primary Analysis |
1.9; 1.3; 1.0; 1.5; 3.2; 2.8 | 0.048 sig |
| SECONDARY Disease-Free Survival (DFS) at the 10-Year Follow-Up |
1.89; 1.27; 1.49; 3.21; 2.80; 2.63 | — |
| SECONDARY Overall Survival (OS) at the Primary Analysis |
1.7; 1.2; 1.7; 2.2; 1.6; 2.1 | 0.078 |
| SECONDARY Overall Survival (OS) at the 10-Year Follow-Up |
1.68; 1.17; 1.75; 2.19; 1.60; 2.07 | — |
| SECONDARY Analysis of Time to Recurrence (TTR) |
243; 275; 298; 43; 38; 46 | — |
| SECONDARY Analysis of Time to Distant Recurrence (TTDR) |
213; 238; 250; 45; 41; 54 | — |
| SECONDARY Analysis of Time to Central Nervous System (CNS) Recurrence |
91; 91; 95; 114; 117; 142 | — |
| SECONDARY Cumulative Incidence of Brain Metastases |
50; 52; 48 | — |
Summary
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer.
Eligibility Criteria
Key Inclusion Criteria
- Patients >= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF >= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status = 1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin ( 2.5 x ULN;
- Alkaline phosphatase (ALP) >2.5 x ULN;
- Serum creatinine >2.0 x ULN;
- Total white blood cell count (WBC) <2.5 x 10^9/L;
- Absolute neutrophil count <1.5 x 10^9/L;
- Platelets <100 x 10^9/L.
- Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women.
- Concomitant use of CYP3A4 inhibitors or inducers.
Data sourced from ClinicalTrials.gov (NCT00490139). 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.