Trial Outcomes & Findings for Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer (NCT NCT00331630)
NCT ID: NCT00331630
Last Updated: 2020-03-06
Results Overview
cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)\>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease \<=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
30 participants
Primary outcome timeframe
At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)
Results posted on
2020-03-06
Participant Flow
The study was opened to accrual May 4th 2006 with the first patient being treated on November 10th 2006. 30 patients were enrolled and treated on the study with the study being closed to new enrollment on June 10th 2009 having reached its accrual goal.
Participant milestones
| Measure |
Treatment Arm
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Treatment on Study
STARTED
|
30
|
|
Treatment on Study
Completed 1st Cycle
|
30
|
|
Treatment on Study
Completed 4 Cycles
|
30
|
|
Treatment on Study
COMPLETED
|
30
|
|
Treatment on Study
NOT COMPLETED
|
0
|
|
Evaluated for and Completed SOC Surgery
STARTED
|
30
|
|
Evaluated for and Completed SOC Surgery
COMPLETED
|
28
|
|
Evaluated for and Completed SOC Surgery
NOT COMPLETED
|
2
|
|
Follow up for 5 Years
STARTED
|
29
|
|
Follow up for 5 Years
COMPLETED
|
0
|
|
Follow up for 5 Years
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Treatment Arm
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Evaluated for and Completed SOC Surgery
Progressive Disease
|
1
|
|
Evaluated for and Completed SOC Surgery
Lost to Follow-up
|
1
|
|
Follow up for 5 Years
Death
|
5
|
|
Follow up for 5 Years
Data collection was stopped
|
24
|
Baseline Characteristics
Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment With Lapatinib and Abraxane
n=30 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)Population: One patient did not have an ultrasound after 4 cycles of treatment prior to surgery
cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)\>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease \<=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Treatment With Lapatinib and Abraxane
n=29 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Clinical Response Rate (cRR)
Complete Response
|
6 participants
|
|
Clinical Response Rate (cRR)
Partial Response
|
18 participants
|
|
Clinical Response Rate (cRR)
Stable Disease
|
5 participants
|
|
Clinical Response Rate (cRR)
Progressive Disease
|
0 participants
|
|
Clinical Response Rate (cRR)
Clinical Response Rate
|
24 participants
|
SECONDARY outcome
Timeframe: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days ) and at surgeryPopulation: One patient did not have an ultrasound after 4 cycles of treatment prior to surgery and one patient was lost to follow up before undergoing surgery
Pathologic Complete Response (pCR) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days) and at surgery. This will be defined as the number of patients that show a pCR after surgery. pCR is defined as the absence of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.
Outcome measures
| Measure |
Treatment With Lapatinib and Abraxane
n=28 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Pathologic Complete Response (pCR)
|
5 Count of Participants
|
SECONDARY outcome
Timeframe: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )Correlation of proliferation (Ki67) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Ki67 scoring was performed based on degree of staining (0= no staining, 1=weak nuclear staining, 2=moderate nuclear staining, 3=strong nuclear staining). Ki67 scores were counted on a maximum of 10 randomly selected x40 high-power fields with an eyepiece grid of 10x10 squares containing representative sections of tumor and calculated as percentage of positively stained cells to total tumor cells (Percent Score method) Ki67 labeling Index (LI) as assessed by counting a maximum of 1,000 malignant cells at x400 magnification.
Outcome measures
| Measure |
Treatment With Lapatinib and Abraxane
n=30 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Proliferation (Ki67) Measured at Baseline and After Completion of Study Treatment
Ki67 pre-treatment
|
31.56 Labeling Index
Standard Deviation 14.47
|
|
Proliferation (Ki67) Measured at Baseline and After Completion of Study Treatment
Ki67 post-treatment
|
30.66 Labeling Index
Standard Deviation 19.86
|
|
Proliferation (Ki67) Measured at Baseline and After Completion of Study Treatment
Ki67 Difference
|
-1.84 Labeling Index
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )Apoptosis/cleaved caspase-3 (CC3) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Scoring was based on the degree of staining (0=more than 90% of tumor cells with no staining, 1= more than 90% of tumor cells have weak staining, 2= more than 90% of tumor cells have moderate staining, 3= more than 90% of tumor cells have strong staining). CC3 scores were counted on a maximum of 10 randomly selected x40 high-power fields with an eyepiece grid of 10x10 squares containing representative sections of tumor and calculated as percentage of positively stained cells to total tumor cells (Percent Score method) CC3 labeling Index (LI) as assessed by counting a maximum of 1,000 malignant cells at x400 magnification.
Outcome measures
| Measure |
Treatment With Lapatinib and Abraxane
n=30 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Apoptosis (Cleaved Caspase-3) Measured at Baseline and After Completion of Study Treatment
CC3 Pre-treatment
|
84.32 Labeling Index
Standard Deviation 28.21
|
|
Apoptosis (Cleaved Caspase-3) Measured at Baseline and After Completion of Study Treatment
CC3 Post-treatment
|
76.58 Labeling Index
Standard Deviation 29.51
|
|
Apoptosis (Cleaved Caspase-3) Measured at Baseline and After Completion of Study Treatment
CC3 Difference
|
-5.26 Labeling Index
Standard Deviation 35.81
|
SECONDARY outcome
Timeframe: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )Angiogenesis (vW, CD34) markers will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Expressions were analyzed by light microscopy in invasive breast cancer regions. Tumor cells were assigned a score: 0 = no staining 1. weak staining less than 1% of tumor cells 2. = medium staining in 1-10% of tumor cells/weak staining in less than 1% of tumor cells 3. = medium or strong staining in more than 10% of the tumor cells. Capillary density was assessed in breast sections stained for CD34 at a x200 magnification by counting the number of capillaries per field with five fields per slide and results expressed as the average number of capillaries per field.
Outcome measures
| Measure |
Treatment With Lapatinib and Abraxane
n=30 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
CD34 Pre-treatment
|
59.54 average number of capillaries per field
Standard Deviation 17.56
|
|
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
CD34 Post-treatment
|
73.12 average number of capillaries per field
Standard Deviation 32.83
|
|
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
CD34 Difference
|
14.69 average number of capillaries per field
Standard Deviation 33.47
|
|
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
vWF Pre-treatment
|
43.11 average number of capillaries per field
Standard Deviation 22.33
|
|
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
vWF Post-treatment
|
49.45 average number of capillaries per field
Standard Deviation 25.33
|
|
Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment
vWF Difference
|
4.79 average number of capillaries per field
Standard Deviation 26.07
|
SECONDARY outcome
Timeframe: At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )Population: Data for HER2/neu and transforming growth factor (TGF-β) was not collected or analyzed.
Epidermal growth factor receptor (EGFR), HER2/neu, matrix metalloproteinases (MMPs), and transforming growth factor (TGF-β) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days) with expressions analyzed by light microscopy in invasive breast cancer regions. MMP2 cytoplasmic staining intensity was assigned a score: 0=no reactivity, 1. =1-10% of tumor cells reactive, 2. =11-25% of tumor cells reactive, 3. = 26-50% of cells reactive, 4. = more than 50% of cells reactive Greater than or equal to 2+ score was considered positive for expression. EGFR membrane staining was assigned a score: 0 = no staining or faint staining in less than 10% of cells 1. = faint incomplete membrane staining in more than 10% of cells 2. = weak to moderate complete membrane staining of more than 10% of cells 3. = strong complete membrane staining in more than 10% of tumor cells
Outcome measures
| Measure |
Treatment With Lapatinib and Abraxane
n=30 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 0 : Pre-treatment
|
21 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 0 : Post-treatment
|
18 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 1+ : Pre-treatment
|
5 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 1+ : Post-treatment
|
3 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 2+ : Pre-treatment
|
0 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 2+ : Post-treatment
|
0 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 3+ : Pre-treatment
|
0 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 3+ : Post-treatment
|
0 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 4+ : Pre-treatment
|
0 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
EGFR 4+ : Post-treatment
|
0 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 0 : Pre-treatment
|
3 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 0 : Post-treatment
|
2 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 1+ : Pre-treatment
|
13 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 1+ : Post-treatment
|
10 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 2+ : Pre-treatment
|
3 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 2+ : Post-treatment
|
2 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 3+ : Pre-treatment
|
1 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 3+ : Post-treatment
|
1 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 4+ : Pre-treatment
|
8 participants
|
|
Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment
MMP-2 4+ : Post-treatment
|
4 participants
|
SECONDARY outcome
Timeframe: At baseline, then before the start of each study treatment cycle (1 cycle = 21 days) beginsSide effects from the combination of Abraxane and Lapatinib will be assessed using CTCAE 3.0. Side effects that were related to study treatment and grade 3 or higher were collected where: Grade 1= Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death
Outcome measures
| Measure |
Treatment With Lapatinib and Abraxane
n=30 Participants
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Side Effects From the Combination of Abraxane and Lapatinib
Fatigue grade 3
|
2 participants
|
|
Side Effects From the Combination of Abraxane and Lapatinib
Rash
|
1 participants
|
|
Side Effects From the Combination of Abraxane and Lapatinib
Diarrhea
|
5 participants
|
|
Side Effects From the Combination of Abraxane and Lapatinib
Bone pain
|
1 participants
|
|
Side Effects From the Combination of Abraxane and Lapatinib
Pruritus
|
1 participants
|
|
Side Effects From the Combination of Abraxane and Lapatinib
Nausea
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, then before each study treatment cycle begins (1 cycle = 21 days)Circulating tumor cell measurement will be assessed by lab tests done at baseline, then before each study treatment cycle begins (1 cycle = 21 days)
Outcome measures
Outcome data not reported
Adverse Events
Treatment With Lapatinib and Abraxane
Serious events: 2 serious events
Other events: 30 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment With Lapatinib and Abraxane
n=30 participants at risk
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Eye disorders
Dry Eyes
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
Other adverse events
| Measure |
Treatment With Lapatinib and Abraxane
n=30 participants at risk
30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
26.7%
8/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
General disorders
Fatigue
|
76.7%
23/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
General disorders
Fever
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
General disorders
Weight Loss
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN: Dry skin
|
13.3%
4/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
43.3%
13/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Scalp Folliculitis
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
6/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Skin Itching
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Skin peeling
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Rash acne
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
20/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS: Anorexia
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Dehydration
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Diarrhea
|
73.3%
22/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Nausea
|
30.0%
9/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Taste alteration(dysgeusia)
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
10.0%
3/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Infections and infestations
Infection
|
13.3%
4/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Blood and lymphatic system disorders
Edema
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
5/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Metabolism and nutrition disorders
Alkaline Phoshatase Increased
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Metabolism and nutrition disorders
AST/ALT Increased
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Metabolism and nutrition disorders
Bilirubin Increased
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Metabolism and nutrition disorders
Albumin Decreased
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Nervous system disorders
Neuropathy:sensory
|
50.0%
15/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Psychiatric disorders
Mood alteration - Depression
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Nervous system disorders
Head/headache
|
16.7%
5/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Nervous system disorders
Insomnia
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
General disorders
Pain
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
General disorders
Bone Pain
|
66.7%
20/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Eye disorders
Blurred Vision
|
10.0%
3/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Eye disorders
Dry Eyes
|
6.7%
2/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
3.3%
1/30 • Patients were followed for 4 cycles of treatment where 1 cycle equals 21 days
Only adverse events that were at least possibly related to the study were recorded and reported on
|
Additional Information
Virginia Kaklamani
Northwestern University
Phone: 312-695-1301
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place