Trial Outcomes & Findings for PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE (NCT NCT00499681)
NCT ID: NCT00499681
Last Updated: 2012-08-10
Results Overview
Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
at 14 weeks
Results posted on
2012-08-10
Participant Flow
This study was open from 07/12/2007 through 12/09/2010.
This is a two-part study. Part I consists of two arms: investigational drug plus Letrozole or placebo and Letrozole. Part II is Letrozole plus Lapatinib. Six patients signed consent. Two patients had toxicity or relapse, thus withdrew from the study.
Participant milestones
| Measure |
Lapatinib + Letrozole, Then Lapatinib + Letrozole
Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
|
Placebo + Letrozole, Then Lapatinib + Letrozole
Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Lapatinib + Letrozole, Then Lapatinib + Letrozole
Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
|
Placebo + Letrozole, Then Lapatinib + Letrozole
Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
|
|---|---|---|
|
Overall Study
toxicity
|
0
|
1
|
|
Overall Study
disease progression
|
0
|
1
|
Baseline Characteristics
PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE
Baseline characteristics by cohort
| Measure |
Lapatinib + Letrozole, Then Lapatinib + Letrozole
n=4 Participants
Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
|
Placebo + Letrozole, Then Lapatinib + Letrozole
n=2 Participants
Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
56.5 years
STANDARD_DEVIATION 1 • n=5 Participants
|
74 years
STANDARD_DEVIATION 1 • n=7 Participants
|
62 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 14 weeksPopulation: Participants who were available for measurement of response.
Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Outcome measures
| Measure |
Part I and Part II Letrozole Plus Laptinab
n=4 Participants
Participants received 2 weeks treatment with letrozole with lapatinib and 14 weeks treatment with letrozole and lapatinib
|
Part 1: Letrozole Plus Placebo Part II Letrozole Plus Laptinab
n=2 Participants
Participants received 2 weeks treatment with letrozole with a placebo and 14 weeks treatment with letrozole and lapatinib
|
|---|---|---|
|
Number of Participants With a Pathological Complete Response
|
1 participants
|
0 participants
|
Adverse Events
Lapatinib + Letrozole, Then Lapatinib + Letrozole
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo + Letrozole, Then Lapatinib + Letrozole
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib + Letrozole, Then Lapatinib + Letrozole
n=4 participants at risk
Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
|
Placebo + Letrozole, Then Lapatinib + Letrozole
n=2 participants at risk
Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
50.0%
1/2 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/4
|
50.0%
1/2 • Number of events 2
|
Other adverse events
| Measure |
Lapatinib + Letrozole, Then Lapatinib + Letrozole
n=4 participants at risk
Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
|
Placebo + Letrozole, Then Lapatinib + Letrozole
n=2 participants at risk
Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
100.0%
4/4 • Number of events 8
|
100.0%
2/2 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 6
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
25.0%
1/4 • Number of events 1
|
100.0%
2/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
50.0%
2/4 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Mucositis, clinical exam
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis, functional/symptomatic
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
dysgeusia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
fatigue
|
75.0%
3/4 • Number of events 7
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
hemorrhoids
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
constitutional symptoms, other
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Psychiatric disorders
insomnia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
rash, acne/acneiform
|
50.0%
2/4 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
skin/dermatology other
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
pruritus/itching
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
pain, other
|
75.0%
3/4 • Number of events 3
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
pain, extremity
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
pain breast
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
pain - NOS
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
pain, headache
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Vascular disorders
hot flashes/flushes
|
25.0%
1/4 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
hemoglobn
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
leukocytes
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
hypokalemia
|
50.0%
2/4 • Number of events 3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
AST, SGOT
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
creatinine
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
hypoglycemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
depressed mood
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
dizziness
|
50.0%
2/4 • Number of events 3
|
0.00%
0/2
|
|
Infections and infestations
infection, bladder
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
muscoloskeletal, soft tissue
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
renal, burning
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
Renal and urinary disorders
urinary, frequency
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
gastrotestinal cramping
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
Additional Information
Ingrid Mayer, MD, Principal Investigator
Vanderbilt-Ingram Cancer Center
Phone: 615-936-2033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place