18 and older, female only, with Neoplasms, Breast. 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.
Number of Participants With Pathological Complete Response (pCR) at the Time of SurgeryPrimary· Weeks 20 to 22
Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.
Group
Value
95% CI
Lapatinib 1500 mg
38
Trastuzumab 2 mg/kg
44
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
78
Number of Participants With Overall Response at Week 6Secondary· Week 6
The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.
Overall Response
Group
Value
95% CI
Lapatinib 1500 mg
81
Trastuzumab 2 mg/kg
45
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
102
No Change
Group
Value
95% CI
Lapatinib 1500 mg
57
Trastuzumab 2 mg/kg
81
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
33
Progressive Disease
Group
Value
95% CI
Lapatinib 1500 mg
5
Trastuzumab 2 mg/kg
11
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
2
Not Evaluated
Group
Value
95% CI
Lapatinib 1500 mg
7
Trastuzumab 2 mg/kg
9
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
12
Missing Data
Group
Value
95% CI
Lapatinib 1500 mg
4
Trastuzumab 2 mg/kg
3
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
3
Overall Response at the Time of SurgerySecondary· Time of surgery (Weeks 20 to 22)
The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.
Overall Response
Group
Value
95% CI
Lapatinib 1500 mg
114
Trastuzumab 2 mg/kg
105
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
122
No Change
Group
Value
95% CI
Lapatinib 1500 mg
8
Trastuzumab 2 mg/kg
16
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
7
Progressive Disease
Group
Value
95% CI
Lapatinib 1500 mg
0
Trastuzumab 2 mg/kg
2
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
1
Not Evaluated
Group
Value
95% CI
Lapatinib 1500 mg
19
Trastuzumab 2 mg/kg
20
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
14
Missing Data
Group
Value
95% CI
Lapatinib 1500 mg
13
Trastuzumab 2 mg/kg
6
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
8
Number of Participants With Negative Lymph Nodes at the Time of SurgerySecondary· Time of surgery (Weeks 20 to 22)
Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis.
Group
Value
95% CI
Lapatinib 1500 mg
72
Trastuzumab 2 mg/kg
82
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
100
Number of Participants With Actual Indicated SurgerySecondary· At surgery (Weeks 20 to 22)
Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable.
Conservative
Group
Value
95% CI
Lapatinib 1500 mg
66
Trastuzumab 2 mg/kg
58
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
63
Non-conservative
Group
Value
95% CI
Lapatinib 1500 mg
77
Trastuzumab 2 mg/kg
85
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
80
Non-operable
Group
Value
95% CI
Lapatinib 1500 mg
11
Trastuzumab 2 mg/kg
6
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
9
Mean Change From Baseline in Tumor Size at Week 6 and at SurgerySecondary· Week 6 and surgery (Weeks 20 to 22)
Mean change from baseline in tumor in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg.
Week 6
Group
Value
95% CI
Lapatinib 1500 mg
-20.45
± 18.43
Trastuzumab 2 mg/kg
-13.42
± 16.44
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
-25.77
± 19.91
Surgery (Weeks 20 to 22)
Group
Value
95% CI
Lapatinib 1500 mg
-41.01
± 23.81
Trastuzumab 2 mg/kg
-35.47
± 22.95
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
-43.59
± 26.88
Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or TrastuzumabSecondary· Week 6
Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel.
Group
Value
95% CI
Lapatinib 1500 mg
8
Trastuzumab 2 mg/kg
12
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
6
Event-free Survival (EFS) - Median Clinical Follow-upSecondary· From randomization up to approximately year 10
Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression.
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
9.69
9.55 – 9.73
Lapatinib 1500 mg
9.60
8.21 – 9.69
Trastuzumab 2 mg/kg
9.66
9.50 – 9.72
Event-free Survival (EFS) - Events and CensoringSecondary· From randomization up to approximately year 10
Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression.
Number of subjects with EFS events
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
43
Lapatinib 1500 mg
47
Trastuzumab 2 mg/kg
47
Number of subjects censored - total
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
109
Lapatinib 1500 mg
107
Trastuzumab 2 mg/kg
102
Number of subjects censored - Clinical follow-up ongoing
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
0
Lapatinib 1500 mg
0
Trastuzumab 2 mg/kg
0
Number of subjects censored - Clinical follow-up ended - total
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
103
Lapatinib 1500 mg
105
Trastuzumab 2 mg/kg
99
Number of subjects censored -Clinical follow-up ended - Completed study follow-up
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
61
Lapatinib 1500 mg
49
Trastuzumab 2 mg/kg
58
Number of subjects censored - Clinical follow-up ended - Lost to follow-up
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
17
Lapatinib 1500 mg
20
Trastuzumab 2 mg/kg
10
Number of subjects censored - Clinical follow-up ended - Withdrew (but consent for survival f/u)
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
3
Lapatinib 1500 mg
6
Trastuzumab 2 mg/kg
4
Number of subjects censored - Clinical follow-up ended - Withdrew
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
22
Lapatinib 1500 mg
30
Trastuzumab 2 mg/kg
27
Overall Survival (OS) - Median Survival Follow-upSecondary· From randomization up to approximately year 10
Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study.
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
9.70
9.60 – 9.76
Lapatinib 1500 mg
9.62
8.86 – 9.67
Trastuzumab 2 mg/kg
9.64
9.35 – 9.71
Overall Survival (OS) - Deaths and CensoringSecondary· From randomization up to approximately year 10
Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study.
Number of deaths due to any cause
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
26
Lapatinib 1500 mg
31
Trastuzumab 2 mg/kg
32
Number of subjects censored - total
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
126
Lapatinib 1500 mg
123
Trastuzumab 2 mg/kg
117
Number of subjects censored - Survival follow-up ongoing
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
0
Lapatinib 1500 mg
0
Trastuzumab 2 mg/kg
0
Number of subjects censored - Survival follow-up ended - total
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
120
Lapatinib 1500 mg
121
Trastuzumab 2 mg/kg
114
Number of subjects censored -Survival follow-up ended - Completed study follow-up
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
74
Lapatinib 1500 mg
59
Trastuzumab 2 mg/kg
62
Number of subjects censored - Survival follow-up ended - Lost to follow-up
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
22
Lapatinib 1500 mg
27
Trastuzumab 2 mg/kg
18
Number of subjects censored - Survival follow-up ended - Withdrew
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
24
Lapatinib 1500 mg
35
Trastuzumab 2 mg/kg
34
Number of subjects censored - Other
Group
Value
95% CI
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
6
Lapatinib 1500 mg
2
Trastuzumab 2 mg/kg
3
Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Median Clinical Follow-up (EFS Landmark Population)Secondary· up to year 10
The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis.
Clinical follow-up is the period during which the patient is monitored such that all recurrence or second primary malignancy (SPM) or contralateral breast cancer (CBC) events would be reported. Patients are considered in clinical follow-up from randomisation until one of the following occurs: lost to follow-up, withdrawal of consent, end of follow-up due to completion of year 10 visit, termination of study follow-up, or death.
Median clinical follow-up - all subjects in the EFS landmark analysis
Group
Value
95% CI
Pathological Complete Response (pCR)
9.05
8.86 – 9.14
No Pathological Complete Response (pCR)
9.11
9.05 – 9.14
Overall
9.09
9.03 – 9.13
Median clinical follow-up- EFS landmark analysis - lapatinib + trastuzumab arm (n=67,71,138)
Group
Value
95% CI
Pathological Complete Response (pCR)
9.13
8.97 – 9.23
No Pathological Complete Response (pCR)
9.10
7.24 – 9.15
Overall
9.12
8.97 – 9.15
Median clinical follow-up - subjects in the EFS landmark analysis - lapatinib arm (n=30,104,134)
Group
Value
95% CI
Pathological Complete Response (pCR)
8.08
6.08 – 9.12
No Pathological Complete Response (pCR)
9.09
8.52 – 9.19
Overall
9.05
8.23 – 9.12
Median clinical follow-up - subjects in the EFS landmark analysis - trastuzumab arm (n=39,99,138)
Group
Value
95% CI
Pathological Complete Response (pCR)
8.98
8.38 – 9.21
No Pathological Complete Response (pCR)
9.12
9.03 – 9.25
Overall
9.11
8.96 – 9.17
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg
Serious: 61/149 (41%)
Deaths: 1/149
Lapatinib 1500 mg
Serious: 58/151 (38%)
Deaths: 2/151
Trastuzumab 2 mg/kg
Serious: 36/148 (24%)
Deaths: 0/148
Serious adverse events (79 terms)
Reaction
System
Lapatinib 1000/750 mg + Tr…
Lapatinib 1500 mg
Trastuzumab 2 mg/kg
HYPERTRANSAMINASAEMIA
Hepatobiliary disorders
—
—
—
NEUTROPENIA
Blood and lymphatic system disorders
—
—
—
DIARRHOEA
Gastrointestinal disorders
—
—
—
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
—
—
—
PYREXIA
General disorders
—
—
—
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
—
—
—
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
—
—
—
VOMITING
Gastrointestinal disorders
—
—
—
URINARY TRACT INFECTION
Infections and infestations
—
—
—
LEUKOPENIA
Blood and lymphatic system disorders
—
—
—
NAUSEA
Gastrointestinal disorders
—
—
—
CELLULITIS
Infections and infestations
—
—
—
MASTITIS
Infections and infestations
—
—
—
PNEUMONIA
Infections and infestations
—
—
—
DEHYDRATION
Metabolism and nutrition disorders
—
—
—
ACUTE KIDNEY INJURY
Renal and urinary disorders
—
—
—
INTERSTITIAL LUNG DISEASE
Respiratory, thoracic and mediastinal disorders
—
—
—
AGRANULOCYTOSIS
Blood and lymphatic system disorders
—
—
—
ANAEMIA
Blood and lymphatic system disorders
—
—
—
PANCYTOPENIA
Blood and lymphatic system disorders
—
—
—
CARDIO-RESPIRATORY ARREST
Cardiac disorders
—
—
—
MYOCARDIAL INFARCTION
Cardiac disorders
—
—
—
DUODENITIS
Gastrointestinal disorders
—
—
—
ENTERITIS
Gastrointestinal disorders
—
—
—
GASTRITIS EROSIVE
Gastrointestinal disorders
—
—
—
Other adverse events (178 terms — click to expand)
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer.
Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this biological window, patients on monotherapy arms will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m\^2 for a further 12 weeks, up to definitive surgery. In the combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab 2 mg/kg IV plus weekly paclitaxel 80mg/m\^2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with 5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant setting for a further 34 weeks (in the combination arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total duration of the anti-HER2 therapy one year.
Primary objective is to evaluate and compare the rate of pathological complete response (pCR) at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03784014 — Molecular Profiling of Advanced Soft-tissue Sarcomas
· Phase 3
· active not recruiting
NCT03523585 — DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
· Phase 3
· completed
NCT04185649 — The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
· Phase 3
· unknown
NCT03500380 — A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without L
· Phase 2, PHASE3
· unknown
NCT03084939 — Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2
· Phase 3
· completed
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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 September 2021
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/NCT00553358.