Trial Outcomes & Findings for 4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ (NCT NCT00952731)
NCT ID: NCT00952731
Last Updated: 2015-07-21
Results Overview
Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline and after 4-10 weeks of treatment
Results posted on
2015-07-21
Participant Flow
Between November 2009 and July 2011, subjects were recruited at Northwestern University and Washington University. The original accrual goal was 112, however, the study was halted early due to drug supply issues.
A total of 31 subjects were registered to the study but only 27 were randomized and began the study. Three participants were deemed ineligible and 1 withdrew consent before randomization.
Participant milestones
| Measure |
Treatment Gel + Oral Placebo
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
Randomization
|
13
|
14
|
|
Overall Study
Treatment & Pre-Surgery
|
12
|
14
|
|
Overall Study
Surgery
|
12
|
14
|
|
Overall Study
Follow-up
|
12
|
14
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Gel + Oral Placebo
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Overall Study
Drug supply expired
|
1
|
0
|
Baseline Characteristics
4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ
Baseline characteristics by cohort
| Measure |
Treatment Gel + Oral Placebo
n=13 Participants
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=14 Participants
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Menopausal status
Pre-Menopausal
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Menopausal status
Post-Menopausal
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 4-10 weeks of treatmentPopulation: 18 total subjects were evaluable for immunohistochemistry marker testing including the Ki-67 labeling index. Of the 26 participants who completed study treatment 2 did not have matching samples available for testing and 6 were excluded because of insufficient DCIS lesion in their samples for testing.
Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).
Outcome measures
| Measure |
Treatment Gel + Oral Placebo
n=9 Participants
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=9 Participants
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment
|
-3.4 percentage of 300 DCIS cells
Standard Deviation 5.0
|
-5.1 percentage of 300 DCIS cells
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline and after 4-10 weeks of treatmentPopulation: 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.
Hot flashes were assessed by the Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire. This questionnaire measures the incidence of a number of symptoms by asking participants how frequently they experienced them on a scale of 0-4 (0 being Not at All and 4 being Extremely often). BESS questionnaire was administered at baseline and time of surgery. The incidence of vasomotor symptoms (including hot flashes, night sweats, and cold sweats) was measured at baseline (Day 0) and end of treatment prior to surgery (at least 4 weeks later or up to 10 weeks, depending on scheduled surgery date), and changes in the mean score for hot flashes were observed.
Outcome measures
| Measure |
Treatment Gel + Oral Placebo
n=12 Participants
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=14 Participants
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery
|
0.33 units on a scale
Standard Deviation 0.64
|
0.55 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline to immediately before surgery (after approximately 4-10 weeks)Population: 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.
The difference between vWF coagulation protein in blood samples collected at baseline and before surgery were measured using the immune-turbidimetric assay.
Outcome measures
| Measure |
Treatment Gel + Oral Placebo
n=12 Participants
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=14 Participants
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery
|
-2.6 percentage of vWF protein in blood
Standard Deviation 52.3
|
51.2 percentage of vWF protein in blood
Standard Deviation 71.0
|
SECONDARY outcome
Timeframe: Baseline and immediately before surgery (after approximately 4-10 weeks)Population: 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.
The difference between Factor VIII coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.
Outcome measures
| Measure |
Treatment Gel + Oral Placebo
n=12 Participants
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=14 Participants
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery
|
8.7 percentage Factor VIII protein in blood
Standard Deviation 18.5
|
11.6 percentage Factor VIII protein in blood
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Baseline and immediately before surgery (after approximately 4-10 weeks)Population: 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.
The difference between Factor IX coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.
Outcome measures
| Measure |
Treatment Gel + Oral Placebo
n=12 Participants
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=14 Participants
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery
|
-5.6 percentage of Factor IX protein in blood
Standard Deviation 13.6
|
0.4 percentage of Factor IX protein in blood
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline and immediately before surgery (after approximately 4-10 weeks)Population: 1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.
The difference between protein S coagulation protein in blood samples collected at baseline and before surgery was measured using an ELISA Kit.
Outcome measures
| Measure |
Treatment Gel + Oral Placebo
n=12 Participants
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=14 Participants
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Difference in Protein S Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery
|
-1.6 percentage of protein S in blood
Standard Deviation 6.5
|
-2.7 percentage of protein S in blood
Standard Deviation 9.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of surgery (after approximately 4-10 weeks)Concentrations of tamoxifen and its metabolites: 4-hydroxytamoxifen, endoxifen, and NDT were measured in breast tissue, blood, and Nipple Aspirate Fluid (NAF) that was collected on the day of surgery.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 28-70 daysDescriptive statistics and confidence intervals will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 28-70 daysDescriptive statistics and confidence intervals will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 28-70 daysDescriptive statistics and confidence intervals will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 28-70 daysDescriptive statistics and confidence intervals will be provided.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Gel + Oral Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Gel + Oral Treatment
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Gel + Oral Placebo
n=12 participants at risk
4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.
oral placebo: Oral placebo taken daily for 4-10 weeks.
afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.
|
Placebo Gel + Oral Treatment
n=14 participants at risk
Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).
tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Sweating (Diaphoresis)
|
33.3%
4/12 • Number of events 10 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
42.9%
6/14 • Number of events 30 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Blood and lymphatic system disorders
Edema
|
16.7%
2/12 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Blood and lymphatic system disorders
Hemorrhage, Gu::Vagina
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Endocrine disorders
Insomnia
|
25.0%
3/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Endocrine disorders
Fatigue
|
33.3%
4/12 • Number of events 4 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
35.7%
5/14 • Number of events 6 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Endocrine disorders
Hot Flashes
|
58.3%
7/12 • Number of events 13 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
50.0%
7/14 • Number of events 26 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Gastrointestinal disorders
Anorexia
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
14.3%
2/14 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
28.6%
4/14 • Number of events 4 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Gastrointestinal disorders
Heartburn/Dyspepsia
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
14.3%
2/14 • Number of events 5 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain
|
41.7%
5/12 • Number of events 5 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Flu -like Syndromes
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Other
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
14.3%
2/14 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Back
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Chest/Thorax Nos
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Extremity/Limb
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
14.3%
2/14 • Number of events 4 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Headache
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
42.9%
6/14 • Number of events 8 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Pain: Nos
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Pain: Stomach
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Immune system disorders
Fever
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Infections and infestations
Infection- Other
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Infections and infestations
Infection with unknown ANC
|
16.7%
2/12 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Metabolism and nutrition disorders
Weight Gain
|
25.0%
3/12 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Nervous system disorders
Mood Alteration
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Nervous system disorders
Cognitive Disturbance
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Nervous system disorders
Memory Impairment
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Reproductive system and breast disorders
Vaginitis (not due to infection)
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Reproductive system and breast disorders
Vaginal discharge (not infectious)
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
14.3%
2/14 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Reproductive system and breast disorders
Irregular Menses
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Reproductive system and breast disorders
Pain: Breast
|
41.7%
5/12 • Number of events 7 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
64.3%
9/14 • Number of events 12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Reproductive system and breast disorders
Pain: Vagina
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
16.7%
2/12 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Cavity/Paranasal Sinus Reactions
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
21.4%
3/14 • Number of events 4 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Voice change/dysarthria
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shorntess of breath)
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
35.7%
5/14 • Number of events 6 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Chest Wall
|
8.3%
1/12 • Number of events 2 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
0.00%
0/12 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
7.1%
1/14 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itching
|
16.7%
2/12 • Number of events 3 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
8.3%
1/12 • Number of events 1 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
0.00%
0/14 • 14 weeks
Patients were asked about any adverse events they may have experienced at every study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place