Trial Outcomes & Findings for Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow (NCT NCT00824538)
NCT ID: NCT00824538
Last Updated: 2018-04-05
Results Overview
DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline, 6 months after start of treatment
Results posted on
2018-04-05
Participant Flow
Patients (pts) were enrolled in this study over the course of a year, from May 2009 through May 2010. A total of 21 patients were screened, and 13 patients, demonstrating ≥ 10 DTCs/mL via bone marrow aspiration, were deemed eligible.
13 patients were enrolled, and 11 received 6-month bone marrow aspirations after completing sunitinib treatment.
Participant milestones
| Measure |
Sunitinib (SU)
Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
Baseline characteristics by cohort
| Measure |
Sunitinib (SU)
n=13 Participants
Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months after start of treatmentDTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL
Outcome measures
| Measure |
Sunitinib (SU)
n=11 Participants
Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
|
|---|---|
|
Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
|
39 percentage of change
Interval 1.0 to 90.0
|
SECONDARY outcome
Timeframe: after 6 months from start of treatmentOutcome measures
| Measure |
Sunitinib (SU)
n=13 Participants
Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
|
|---|---|
|
Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study
|
11 participants
|
SECONDARY outcome
Timeframe: up to 7 months after start of treatmentOutcome measures
| Measure |
Sunitinib (SU)
n=13 Participants
Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
|
|---|---|
|
Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0
|
13 participants
|
SECONDARY outcome
Timeframe: up to 3 years from beginning of treatmentData was not collected due to emerging data on toxicity and competing trials.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After one year of treatmentData was not collected due to emerging data on toxicity and competing trials.
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib (SU)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sunitinib (SU)
n=13 participants at risk
Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
|
|---|---|
|
Reproductive system and breast disorders
ache in the axillary
|
7.7%
1/13
|
|
Psychiatric disorders
agitation
|
7.7%
1/13
|
|
Investigations
alanine aminotransferase increased
|
7.7%
1/13
|
|
Investigations
alkaline phosphatase increased
|
15.4%
2/13
|
|
Skin and subcutaneous tissue disorders
alopecia
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
anemia
|
23.1%
3/13
|
|
Metabolism and nutrition disorders
anorexia
|
7.7%
1/13
|
|
Psychiatric disorders
anxiety
|
23.1%
3/13
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
61.5%
8/13
|
|
Investigations
aspartate aminotransferase increased
|
30.8%
4/13
|
|
Musculoskeletal and connective tissue disorders
back pain
|
15.4%
2/13
|
|
Investigations
blood bilirubin increased
|
7.7%
1/13
|
|
Eye disorders
Blurred vision
|
15.4%
2/13
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
7.7%
1/13
|
|
Reproductive system and breast disorders
breast pain
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
bruising
|
23.1%
3/13
|
|
General disorders
chills
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
30.8%
4/13
|
|
Gastrointestinal disorders
constipation
|
30.8%
4/13
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
30.8%
4/13
|
|
Investigations
creatinine increased
|
15.4%
2/13
|
|
Psychiatric disorders
depression
|
7.7%
1/13
|
|
Gastrointestinal disorders
diarrhea
|
53.8%
7/13
|
|
Nervous system disorders
dizziness
|
23.1%
3/13
|
|
Eye disorders
dry eye
|
15.4%
2/13
|
|
Skin and subcutaneous tissue disorders
dry skin
|
38.5%
5/13
|
|
Respiratory, thoracic and mediastinal disorders
dry throat
|
7.7%
1/13
|
|
Nervous system disorders
dysgeusia
|
15.4%
2/13
|
|
Gastrointestinal disorders
dyspepsia
|
23.1%
3/13
|
|
Gastrointestinal disorders
dysphagia
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
23.1%
3/13
|
|
Ear and labyrinth disorders
ears plugged
|
7.7%
1/13
|
|
General disorders
edema face
|
7.7%
1/13
|
|
General disorders
fatigue
|
84.6%
11/13
|
|
Nervous system disorders
feet numbness
|
7.7%
1/13
|
|
Eye disorders
flashing light
|
23.1%
3/13
|
|
Gastrointestinal disorders
flatulence
|
7.7%
1/13
|
|
Eye disorders
floaters
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
hand-foot syndrome
|
30.8%
4/13
|
|
Nervous system disorders
headache
|
53.8%
7/13
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
15.4%
2/13
|
|
Vascular disorders
hot flashes
|
30.8%
4/13
|
|
Metabolism and nutrition disorders
hyperkalemia
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
hypernatremia
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
7.7%
1/13
|
|
Vascular disorders
hypertension
|
23.1%
3/13
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
hypocalcemia
|
23.1%
3/13
|
|
Metabolism and nutrition disorders
hypokalemia
|
15.4%
2/13
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
7.7%
1/13
|
|
Endocrine disorders
hypothyroidism
|
30.8%
4/13
|
|
Psychiatric disorders
insomnia
|
30.8%
4/13
|
|
Nervous system disorders
lightheadedness
|
7.7%
1/13
|
|
Reproductive system and breast disorders
lumpy breast
|
7.7%
1/13
|
|
Investigations
lymphocyte count decreased
|
15.4%
2/13
|
|
Nervous system disorders
memory impairment
|
7.7%
1/13
|
|
Gastrointestinal disorders
mucositis oral
|
53.8%
7/13
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
23.1%
3/13
|
|
Gastrointestinal disorders
nausea
|
46.2%
6/13
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
7.7%
1/13
|
|
Nervous system disorders
neuralgia
|
7.7%
1/13
|
|
Investigations
neutrophil count decreased
|
92.3%
12/13
|
|
Vascular disorders
night sweat
|
7.7%
1/13
|
|
General disorders
non-cardiac chest pain
|
7.7%
1/13
|
|
Reproductive system and breast disorders
numbness in the axillary
|
7.7%
1/13
|
|
Gastrointestinal disorders
oral dysesthesia
|
23.1%
3/13
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
92.3%
12/13
|
|
Skin and subcutaneous tissue disorders
pain of skin
|
7.7%
1/13
|
|
Nervous system disorders
peripheral sensory neuropathy
|
46.2%
6/13
|
|
Eye disorders
photophobia
|
7.7%
1/13
|
|
Investigations
platelet count decreased
|
53.8%
7/13
|
|
Skin and subcutaneous tissue disorders
rash
|
38.5%
5/13
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis
|
15.4%
2/13
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
23.1%
3/13
|
|
Eye disorders
subconjunctival hemorrhage
|
7.7%
1/13
|
|
Renal and urinary disorders
urinary frequency
|
15.4%
2/13
|
|
Renal and urinary disorders
urinary tract infection
|
7.7%
1/13
|
|
Reproductive system and breast disorders
vaginal dryness
|
15.4%
2/13
|
|
Gastrointestinal disorders
vomiting
|
15.4%
2/13
|
|
Investigations
weight loss
|
7.7%
1/13
|
|
Investigations
white blood cell decreased
|
84.6%
11/13
|
|
Skin and subcutaneous tissue disorders
white hair
|
23.1%
3/13
|
|
Infections and infestations
wound infection
|
7.7%
1/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place