18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS) at the Time of Primary ResultsPrimary· From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
Intent-to-Treat (ITT) population
Group
Value
95% CI
Lapatinib (LTax/L)
8.97
0.30 – 32.69
Trastuzumab (TTax/T)
11.30
0.30 – 38.54
centrally-confirmed HER2 positive population
Group
Value
95% CI
Lapatinib (LTax/L)
9.13
0.30 – 32.69
Trastuzumab (TTax/T)
13.63
0.30 – 38.54
Progression Free Survival (PFS) at the Time of Final AnalysisSecondary· From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at the last PFS assessment before crossover.
Intent-to-Treat (ITT) population
Group
Value
95% CI
Lapatinib (LTax/L)
9.1
8.5 – 10.8
Trastuzumab (TTax/T)
11.5
10.9 – 13.8
centrally-confirmed HER2 positive population
Group
Value
95% CI
Lapatinib (LTax/L)
9.4
8.5 – 11.0
Trastuzumab (TTax/T)
13.8
11.2 – 14.2
Overall Survival (OS) (IIT Population)Secondary· From date of randomization until date of death from any cause, assessed up approximately 165 months
Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover.
Group
Value
95% CI
Lapatinib (LTax/L)
30.0
24.2 – NA
Trastuzumab (TTax/T)
38.3
31.0 – NA
Overall Survival (OS) (Central HER2+ Population)Secondary· From date of randomization until date of death from any cause, assessed up approximately 165 months
Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover.
Group
Value
95% CI
Lapatinib (LTax/L)
30.0
24.2 – NA
Trastuzumab (TTax/T)
NA
NA – NA
Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population)Secondary· From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects.
Subject had CNS metastasis at first progression = Yes
Group
Value
95% CI
Lapatinib (LTax/L)
47
Trastuzumab (TTax/T)
55
Crossed Over to Trastuzumab (TTax/T) After IA Results
1
Overall TTax/T
56
Subject had CNS metastasis at first progression = No
Group
Value
95% CI
Lapatinib (LTax/L)
155
Trastuzumab (TTax/T)
119
Crossed Over to Trastuzumab (TTax/T) After IA Results
4
Overall TTax/T
123
Subject had CNS metastasis at first progression = Unknown
Group
Value
95% CI
Lapatinib (LTax/L)
66
Trastuzumab (TTax/T)
62
Crossed Over to Trastuzumab (TTax/T) After IA Results
0
Overall TTax/T
62
Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population)Secondary· From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects.
Subject had CNS metastasis at first progression = Yes
Group
Value
95% CI
Lapatinib (LTax/L)
43
Trastuzumab (TTax/T)
50
Crossed Over to Trastuzumab (TTax/T) After IA Results
1
Overall TTax/T
51
Subject had CNS metastasis at first progression = No
Group
Value
95% CI
Lapatinib (LTax/L)
128
Trastuzumab (TTax/T)
92
Crossed Over to Trastuzumab (TTax/T) After IA Results
3
Overall TTax/T
95
Subject had CNS metastasis at first progression = Unknown
Group
Value
95% CI
Lapatinib (LTax/L)
53
Trastuzumab (TTax/T)
44
Crossed Over to Trastuzumab (TTax/T) After IA Results
0
Overall TTax/T
44
Time to Central Nervous System (CNS) Metastasis (IIT Population)Secondary· From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover.
Group
Value
95% CI
Lapatinib (LTax/L)
NA
NA – NA
Trastuzumab (TTax/T)
NA
NA – NA
Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population)Secondary· From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover.
Group
Value
95% CI
Lapatinib (LTax/L)
NA
25.4 – NA
Trastuzumab (TTax/T)
NA
27.7 – NA
Overall Response Rate (ORR) (IIT Population)Secondary· From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages.
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI:
* Complete Response (CR): Disappearance of all target and non-target lesions.
* Partial Re
Group
Value
95% CI
Lapatinib (LTax/L)
64.2
58.0 – 70.1
Trastuzumab (TTax/T)
63.3
57.3 – 69.1
Overall Response Rate (ORR) (Central HER2+ Population)Secondary· From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages.
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI:
* Complete Response (CR): Disappearance of all target and non-target lesions.
* Partial Re
Group
Value
95% CI
Lapatinib (LTax/L)
66.7
60.0 – 72.9
Trastuzumab (TTax/T)
67.4
60.8 – 73.5
Clinical Benefit Response (CBR) (IIT Population)Secondary· From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Clinical Benefit Response (CBR) was defined as the percentage with evidence of Complete Response (CR), Partial Response (PR) (participants with at least 1 measurable lesion at baseline), or maintaining Stable Disease (SD) for at least 24 weeks (all subjects, with or without measurable disease at baseline) while on study, according to the investigator assessment of response per RECIST 1.1 criteria. Participants were considered to be positive (Yes) for CBR if they experienced any CR or PR for any duration prior to progressive disease. Participants were considered to be negative (No) for CBR if t
Group
Value
95% CI
Lapatinib (LTax/L)
60.4
54.9 – 65.8
Trastuzumab (TTax/T)
62.0
56.5 – 67.3
Clinical Benefit Response (CBR) (Central HER2+ Population)Secondary· From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Clinical Benefit Response (CBR) was defined as the percentage with evidence of Complete Response (CR), Partial Response (PR) (participants with at least 1 measurable lesion at baseline), or maintaining Stable Disease (SD) for at least 24 weeks (all subjects, with or without measurable disease at baseline) while on study, according to the investigator assessment of response per RECIST 1.1 criteria. Participants were considered to be positive (Yes) for CBR if they experienced any CR or PR for any duration prior to progressive disease. Participants were considered to be negative (No) for CBR if t
Group
Value
95% CI
Lapatinib (LTax/L)
61.1
55.0 – 67.0
Trastuzumab (TTax/T)
65.2
59.1 – 70.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 28 days post-treat follow-up, assessed up to approximately 165 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 166 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lapatinib (LTax/L) - All Participants
Serious: 106/322 (33%)
Deaths: 21/326
Trastuzumab (TTax/T)
Serious: 66/325 (20%)
Deaths: 13/326
Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results
Serious: 2/5 (40%)
Deaths: 0/5
Lapatinib (LTax/L) - All Participants (Post-treatment)
Serious: 0
Deaths: 82/301
Trastuzumab (TTax/T) (Post-treatment)
Serious: 0
Deaths: 73/312
Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results (Post-treatment)
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06278870 — Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
· Phase 3
· recruiting
NCT07421141 — De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer
· Phase 2
· active not recruiting
NCT05253651 — A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colo
· Phase 3
· recruiting
NCT05091528 — A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
· Phase 1, PHASE2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 21 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00667251.