Trial Outcomes & Findings for LY353381 in Preventing Breast Cancer in Women With Hyperplasia (NCT NCT00005879)
NCT ID: NCT00005879
Last Updated: 2017-05-30
Results Overview
Change in the semi-quantitative score assigned by the designated cytopathologist. Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2017-05-30
Participant Flow
Screen by random periareolar fine needle aspiration for presence of hyperplasia or hyperplasia with atypia.
Participant milestones
| Measure |
Placebo
Placebo
Placebo: matched tablet dialy
|
Arzoxifene
LY353381, 20 mg daily
arzoxifene: one tablet daily
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
98
|
|
Overall Study
COMPLETED
|
93
|
88
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
Placebo: matched tablet dialy
|
Arzoxifene
LY353381, 20 mg daily
arzoxifene: one tablet daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
Baseline Characteristics
LY353381 in Preventing Breast Cancer in Women With Hyperplasia
Baseline characteristics by cohort
| Measure |
Placebo
n=101 Participants
Placebo
Placebo: matched tablet dialy
|
Arzoxifene
n=98 Participants
LY353381, 20 mg daily
arzoxifene: one tablet daily
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
199 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
|
101 participants
n=5 Participants
|
98 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
Height
|
64.8 inches
STANDARD_DEVIATION 2.6 • n=5 Participants
|
65.1 inches
STANDARD_DEVIATION 2.4 • n=7 Participants
|
65.0 inches
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Weight
|
156 lb
STANDARD_DEVIATION 32 • n=5 Participants
|
157 lb
STANDARD_DEVIATION 40 • n=7 Participants
|
156 lb
STANDARD_DEVIATION 36 • n=5 Participants
|
|
BMI
|
26.3 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 5.8 • n=7 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Menopause Status
Pre
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Menopause Status
Post
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Hormone Use
None
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Hormone Use
OC or HRT Use
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age at Menarche
|
12.78 years
STANDARD_DEVIATION 1.42 • n=5 Participants
|
12.82 years
STANDARD_DEVIATION 1.45 • n=7 Participants
|
12.79 years
STANDARD_DEVIATION 1.43 • n=5 Participants
|
|
Age at First Live Birth
|
20.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
20.2 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
20.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Prior Biopsy
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Number relatives with Breast Cancer
0 Relatives
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Number relatives with Breast Cancer
1 Relative
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Number relatives with Breast Cancer
2 Relatives
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Number relatives with Breast Cancer
3 Relatives
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in Masood score.
Change in the semi-quantitative score assigned by the designated cytopathologist. Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo
Placebo: matched tablet dialy
|
Arzoxifene
n=82 Participants
LY353381, 20 mg daily
arzoxifene: one tablet daily
|
|---|---|---|
|
Change in Masood Score
|
-1.1 units on a scale
Standard Deviation 1.9
|
-0.8 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in cytomorphology category.
Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist. Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia.
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo
Placebo: matched tablet dialy
|
Arzoxifene
n=82 Participants
LY353381, 20 mg daily
arzoxifene: one tablet daily
|
|---|---|---|
|
Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months
No Improvement
|
53 Participants
|
52 Participants
|
|
Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months
Improvement
|
31 Participants
|
30 Participants
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 100 other events
Deaths: 0 deaths
Arzoxifene
Serious events: 9 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=101 participants at risk
Placebo
Placebo: matched tablet dialy
|
Arzoxifene
n=98 participants at risk
LY353381, 20 mg daily
arzoxifene: one tablet daily
|
|---|---|---|
|
Gastrointestinal disorders
APPENDICITIS
|
2.0%
2/101 • Number of events 2 • Duration on study agent, nominally a maximum of 12 months.
|
0.00%
0/98 • Duration on study agent, nominally a maximum of 12 months.
|
|
Musculoskeletal and connective tissue disorders
SLIPPED DISK
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.99%
1/101 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Gastrointestinal disorders
ISCHEMIC COLITIS
|
0.99%
1/101 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
0.00%
0/98 • Duration on study agent, nominally a maximum of 12 months.
|
|
Reproductive system and breast disorders
UTERINE DISORDER / MULTIPLE UTERINE FIBROIDS
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Vascular disorders
ANGIOEDEMA
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS RIGHT CALF
|
0.99%
1/101 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
0.00%
0/98 • Duration on study agent, nominally a maximum of 12 months.
|
|
Musculoskeletal and connective tissue disorders
RIGHT BIMALLEOLAR ANKLE FRACTURE
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Eye disorders
BILATERAL CATARACTS
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKEMIA
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PRIMARY DCIS IN BREAST
|
0.00%
0/101 • Duration on study agent, nominally a maximum of 12 months.
|
1.0%
1/98 • Number of events 1 • Duration on study agent, nominally a maximum of 12 months.
|
Other adverse events
| Measure |
Placebo
n=101 participants at risk
Placebo
Placebo: matched tablet dialy
|
Arzoxifene
n=98 participants at risk
LY353381, 20 mg daily
arzoxifene: one tablet daily
|
|---|---|---|
|
General disorders
Asthenia
|
20.8%
21/101 • Number of events 33 • Duration on study agent, nominally a maximum of 12 months.
|
35.7%
35/98 • Number of events 54 • Duration on study agent, nominally a maximum of 12 months.
|
|
General disorders
Vasodilation
|
32.7%
33/101 • Number of events 72 • Duration on study agent, nominally a maximum of 12 months.
|
59.2%
58/98 • Number of events 74 • Duration on study agent, nominally a maximum of 12 months.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
15.8%
16/101 • Number of events 39 • Duration on study agent, nominally a maximum of 12 months.
|
41.8%
41/98 • Number of events 55 • Duration on study agent, nominally a maximum of 12 months.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
27.7%
28/101 • Number of events 59 • Duration on study agent, nominally a maximum of 12 months.
|
64.3%
63/98 • Number of events 73 • Duration on study agent, nominally a maximum of 12 months.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
19.8%
20/101 • Number of events 37 • Duration on study agent, nominally a maximum of 12 months.
|
34.7%
34/98 • Number of events 37 • Duration on study agent, nominally a maximum of 12 months.
|
|
Renal and urinary disorders
Urinary Frequency
|
12.9%
13/101 • Number of events 22 • Duration on study agent, nominally a maximum of 12 months.
|
23.5%
23/98 • Number of events 26 • Duration on study agent, nominally a maximum of 12 months.
|
|
Reproductive system and breast disorders
Vaginitis
|
18.8%
19/101 • Number of events 31 • Duration on study agent, nominally a maximum of 12 months.
|
29.6%
29/98 • Number of events 37 • Duration on study agent, nominally a maximum of 12 months.
|
Additional Information
Bruce F. Kimler, Ph.D.
University of Kansas Medical Center
Phone: 913-588-4523
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place