Trial Outcomes & Findings for Lapatinib and Trastuzumab With or Without Endocrine Therapy (NCT NCT00548184)
NCT ID: NCT00548184
Last Updated: 2019-11-07
Results Overview
Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-11-07
Participant Flow
Participant milestones
| Measure |
Lapatinib + Trastuzumab
All study participants received lapatinib 1000mg daily and Trastuzumab 4mg/kg loading dose and then 2mg/kg every week
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Lapatinib + Trastuzumab
All study participants received lapatinib 1000mg daily and Trastuzumab 4mg/kg loading dose and then 2mg/kg every week
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
took other drug
|
1
|
|
Overall Study
Found Her2 negative
|
1
|
Baseline Characteristics
Lapatinib and Trastuzumab With or Without Endocrine Therapy
Baseline characteristics by cohort
| Measure |
Lapatinib + Trastuzumab
n=65 Participants
All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
|
|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 65 patients were enrolled and received the study treatment. 1 patient was found ineligible for this study therefore she was excluded from outcome report.
Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.
Outcome measures
| Measure |
Lapatinib + Trastuzumab
n=64 Participants
All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week
|
|---|---|
|
Pathologic Assessment After Study Treatment
Complete Pathologic Response
|
18 participants
|
|
Pathologic Assessment After Study Treatment
Near Complete Pathologic Response
|
16 participants
|
|
Pathologic Assessment After Study Treatment
Not Pathologic response
|
30 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one yearOutcome measures
Outcome data not reported
Adverse Events
Lapatinib + Trastuzumab
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib + Trastuzumab
n=65 participants at risk
All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.5%
1/65 • Number of events 1 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
3.1%
2/65 • Number of events 2 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
1.5%
1/65 • Number of events 1 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
1.5%
1/65 • Number of events 1 • study treatment up to 12 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/65 • Number of events 1 • study treatment up to 12 weeks
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas
|
1.5%
1/65 • Number of events 1 • study treatment up to 12 weeks
|
Other adverse events
| Measure |
Lapatinib + Trastuzumab
n=65 participants at risk
All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT
|
23.1%
15/65 • Number of events 19 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
AST, SGOT
|
18.5%
12/65 • Number of events 18 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
10.8%
7/65 • Number of events 10 • study treatment up to 12 weeks
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
6.2%
4/65 • Number of events 4 • study treatment up to 12 weeks
|
|
Immune system disorders
Allergic rhinitis
|
7.7%
5/65 • Number of events 5 • study treatment up to 12 weeks
|
|
Gastrointestinal disorders
Anorexia
|
6.2%
4/65 • Number of events 4 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Bilirubin
|
7.7%
5/65 • Number of events 9 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Calcium, serum-low
|
7.7%
5/65 • Number of events 7 • study treatment up to 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
66.2%
43/65 • Number of events 55 • study treatment up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
18.5%
12/65 • Number of events 12 • study treatment up to 12 weeks
|
|
General disorders
Fatigue
|
32.3%
21/65 • Number of events 21 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
16.9%
11/65 • Number of events 18 • study treatment up to 12 weeks
|
|
Gastrointestinal disorders
HEARTBURN
|
18.5%
12/65 • Number of events 12 • study treatment up to 12 weeks
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
21.5%
14/65 • Number of events 19 • study treatment up to 12 weeks
|
|
Endocrine disorders
Hot flashes/flushes
|
15.4%
10/65 • Number of events 10 • study treatment up to 12 weeks
|
|
Cardiac disorders
Hypertension
|
10.8%
7/65 • Number of events 7 • study treatment up to 12 weeks
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
9.2%
6/65 • Number of events 6 • study treatment up to 12 weeks
|
|
General disorders
Insomnia
|
10.8%
7/65 • Number of events 7 • study treatment up to 12 weeks
|
|
Nervous system disorders
Mood alteration
|
12.3%
8/65 • Number of events 8 • study treatment up to 12 weeks
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
12.3%
8/65 • Number of events 8 • study treatment up to 12 weeks
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
7.7%
5/65 • Number of events 5 • study treatment up to 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
30.8%
20/65 • Number of events 20 • study treatment up to 12 weeks
|
|
General disorders
pain
|
15.4%
10/65 • Number of events 13 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Potassium, serum-low
|
20.0%
13/65 • Number of events 18 • study treatment up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
13.8%
9/65 • Number of events 13 • study treatment up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.8%
7/65 • Number of events 8 • study treatment up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
46.2%
30/65 • Number of events 35 • study treatment up to 12 weeks
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
9.2%
6/65 • Number of events 8 • study treatment up to 12 weeks
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
7.7%
5/65 • Number of events 5 • study treatment up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place