Trial Outcomes & Findings for Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer (NCT NCT00853996)
NCT ID: NCT00853996
Last Updated: 2018-01-17
Results Overview
Change in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2018-01-17
Participant Flow
Participant milestones
| Measure |
Prevention (Acolbifene Hydrochloride)
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer
Baseline characteristics by cohort
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Height
|
65 inches
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Weight
|
155 pounds
STANDARD_DEVIATION 29 • n=5 Participants
|
|
BMI
|
25.8 kg/m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
5-Year Gail Risk
|
3.6 Percent risk of developing breast cancer
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Age First Live Birth
|
28 years
STANDARD_DEVIATION 4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsChange in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.
Outcome measures
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months
|
-3.0 percentage of positive cells
Interval -20.2 to 2.8
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: One subject was without a digital file due to technical reasons. Thus, only 24 subjects were evaluated.
Change in mammographic density from baseline to 6 months, The Percent Breast Density is estimated using the Cumulus computer-assisted program to define a region that is at greater density than the remainder of the breast.
Outcome measures
| Measure |
Prevention (Acolbifene Hydrochloride)
n=24 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Change in Mammographic Breast Density
|
-3.9 percentage of area at increased density
Interval -31.4 to 16.2
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsChange in serum concentration of estradiol from baseline to 6 months
Outcome measures
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Change in Serum Estradiol Concentration
|
64.6 ng/ml
Standard Deviation 138
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsChange in serum concentration of bioavailable estradiol (adjusted for concentration of Sex Hormone Binding Globulin), from baseline to 6 months
Outcome measures
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Change in Serum Concentration of Bioavailable Estradiol
|
2.6 pM
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsChange in serum concentration of Testosterone from baseline to 6 months
Outcome measures
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Change in Serum Concentration of Testosterone
|
0.22 ng/ml
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline to up to 2 weeks post-treatmentProblems with hot flashes were assessed by average number per day and intensity.
Outcome measures
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System
Increase in hot flash frequency and/or severity
|
6 Participants
|
|
Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System
No change in hot flash frequency and/or severity
|
14 Participants
|
|
Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System
Decrease in hot flash frequency and/or severity
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to 2 weeks post-treatmentThe Health Assessment Questionnaire II (HAQ-II) measures interference in daily activities from arthralgias and joint pain. Range 0 - 4. A higher score indicates greater (i.e., "worse") interference.
Outcome measures
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 Participants
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Reports of Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire
Increase in HAQ score
|
1 Participants
|
|
Reports of Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire
No Change in HAQ score
|
24 Participants
|
|
Reports of Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire
Decrease in HAQ score
|
0 Participants
|
Adverse Events
Prevention (Acolbifene Hydrochloride)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prevention (Acolbifene Hydrochloride)
n=25 participants at risk
Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
acolbifene hydrochloride: Given orally
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bilateral knee pain
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg cramps
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Breast tenderness
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Cervical laceration
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Decreased libido
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
General disorders
Diaphoresis
|
4.0%
1/25 • Number of events 2 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • Number of events 5 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Finger joint stiffness
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Respiratory, thoracic and mediastinal disorders
Heavy bleeding with menses
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Endocrine disorders
Hot Flashes
|
20.0%
5/25 • Number of events 7 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Irregular menses
|
12.0%
3/25 • Number of events 4 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Irregular prolonged menses
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Bilateral ankle pain
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
12.0%
3/25 • Number of events 4 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Endocrine disorders
Night Sweats
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Intercourse pain
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Right ovarian cyst
|
8.0%
2/25 • Number of events 2 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Skin and subcutaneous tissue disorders
Palpable right breast mass
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Skin and subcutaneous tissue disorders
Acne (scalp and neck)
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Nervous system disorders
Severe mood swings
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Infections and infestations
Shingles (left flank)
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Infections and infestations
Sinus infection
|
8.0%
2/25 • Number of events 2 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Musculoskeletal and connective tissue disorders
Stiffness in left foot
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Infections and infestations
Viral sinusitis
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
General disorders
Worsening Fatigue
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Immune system disorders
Cold or allergies
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Infections and infestations
Cold sores
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 2 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Gastrointestinal disorders
Intermittent diarrhea
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Nervous system disorders
Migraine
|
4.0%
1/25 • Number of events 1 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Abnormal PAP smear
|
8.0%
2/25 • Number of events 2 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
|
Reproductive system and breast disorders
Amenorrhea
|
16.0%
4/25 • Number of events 4 • From first administration of study agent, through 2 weeks following the planned 6 month duration of study agent.
|
Additional Information
Bruce F. Kimler Ph.D
University of Kansas Mecical Center
Phone: 913-588-4523
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place