Trial Outcomes & Findings for Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy (NCT NCT02314156)
NCT ID: NCT02314156
Last Updated: 2023-02-22
Results Overview
Post-therapy mean levels of telapristone acetate in breast tissue.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
At the time of mastectomy, up to 5 weeks from baseline
Results posted on
2023-02-22
Participant Flow
Participant milestones
| Measure |
Arm I (Transdermal Telapristone Acetate)
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
COMPLETED
|
31
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Transdermal Telapristone Acetate)
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
Baseline characteristics by cohort
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=33 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=34 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 13.41 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of mastectomy, up to 5 weeks from baselinePopulation: Participants with post-therapy breast tissue samples
Post-therapy mean levels of telapristone acetate in breast tissue.
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=28 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=31 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Mean Levels of Telapristone Acetate in Breast Tissue
|
2.82 ng/g
Interval 1.37 to 5.47
|
103 ng/g
Interval 46.3 to 336.0
|
SECONDARY outcome
Timeframe: At the time of mastectomy, up to 5 weeks from baselinePopulation: Participants with plasma samples post-therapy.
Post-therapy plasma concentrations of telapristone acetate.
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=28 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=32 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Plasma Concentrations of Telapristone Acetate
|
0.93 ng/ml
Interval 0.39 to 1.41
|
69.0 ng/ml
Interval 32.8 to 138.0
|
SECONDARY outcome
Timeframe: At the time of mastectomy, up to 5 weeks from baselinePopulation: Participants with post-therapy breast tissue samples.
Post-therapy concentrations of telapristone acetate in 5 locations within breast tissue.
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=28 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=31 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate
Lateral Center
|
2.42 ng/g
Interval 0.42 to 5.2
|
85.5 ng/g
Interval 40.6 to 292.0
|
|
Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate
Medial Center
|
2.79 ng/g
Interval 1.44 to 4.27
|
121 ng/g
Interval 37.9 to 389.0
|
|
Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate
Central Subalveolar
|
1.73 ng/g
Interval 1.15 to 3.61
|
63.7 ng/g
Interval 37.7 to 205.0
|
|
Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate
Central Deepest
|
5.09 ng/g
Interval 2.12 to 10.8
|
133 ng/g
Interval 34.9 to 248.0
|
|
Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate
Lateral Surface
|
6.76 ng/g
Interval 2.55 to 15.5
|
214 ng/g
Interval 104.0 to 354.0
|
SECONDARY outcome
Timeframe: Baseline to mastectomy (up to 5 weeks)Population: Participants with ER positive tumors.
Changes in cell proliferation (Ki67 labeling index) measured in percentage of positive cells from baseline to mastectomy by tumor status in ER positive tumors.
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=17 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=15 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Changes in Cell Proliferation
|
-0.67 % positive
Interval -2.8 to 0.57
|
5.2 % positive
Interval -5.9 to 6.9
|
SECONDARY outcome
Timeframe: Baseline to mastectomy, up to 5 weeks post-interventionPopulation: Premenopausal women
Change in estradiol in premenopausal women from baseline to post-intervention compared between treatment groups
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=18 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=18 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Changes in Serum Sex Hormone Concentrations: Estradiol
|
95.9 pg/ml
Interval 75.1 to 135.0
|
-23.7 pg/ml
Interval -97.5 to -1.7
|
SECONDARY outcome
Timeframe: Baseline to mastectomy (up to 5 weeks)Population: participants
Mean change in symptoms as captured using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=31 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=32 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Body Image
|
0.52 score on a scale
Standard Error 0.34
|
-0.16 score on a scale
Standard Error 0.25
|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Vaginal
|
-0.35 score on a scale
Standard Error 0.20
|
0.19 score on a scale
Standard Error 0.27
|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Cognitive
|
-0.61 score on a scale
Standard Error 0.53
|
-0.88 score on a scale
Standard Error 0.43
|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Body Pain
|
-0.81 score on a scale
Standard Error 0.44
|
-0.78 score on a scale
Standard Error 0.43
|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Vasomotor
|
0.71 score on a scale
Standard Error 0.26
|
0.09 score on a scale
Standard Error 0.23
|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Gastrointestinal
|
0.16 score on a scale
Standard Error 0.35
|
-0.34 score on a scale
Standard Error 0.11
|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Sexual problems
|
-0.29 score on a scale
Standard Error 0.24
|
-0.28 score on a scale
Standard Error 0.19
|
|
Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire
Bladder
|
-0.32 score on a scale
Standard Error 0.18
|
-0.38 score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline to mastectomy (up to 5 weeks)Population: Premenopausal women
Change in progesterone in premenopausal women from baseline to post-intervention compared between treatment groups
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=18 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=18 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Changes in Serum Sex Hormone Concentrations: Progesterone
|
0.19 ng/ml
Interval -0.12 to 1.51
|
-2.36 ng/ml
Interval -10.1 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to mastectomy (up to 5 weeks)Population: Premenopausal women
Change in FSH in premenopausal women from baseline to post-intervention compared between treatment groups
Outcome measures
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=18 Participants
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=18 Participants
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
Changes in Serum Sex Hormone Concentrations: FSH
|
1.91 mIU
Interval -0.4 to 4.28
|
0.30 mIU
Interval -2.84 to 2.21
|
Adverse Events
Arm I (Transdermal Telapristone Acetate)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm II (Oral Telapristone Acetate)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Transdermal Telapristone Acetate)
n=33 participants at risk
Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.
Telapristone Acetate: Given transdermally applied to both breast skin
Placebo: Given PO
|
Arm II (Oral Telapristone Acetate)
n=34 participants at risk
Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.
Telapristone Acetate: Given PO
Placebo: Given transdermally applied to both breast skin
|
|---|---|---|
|
General disorders
General disorders and administrative site condition - other specify
|
18.2%
6/33 • Number of events 10 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
20.6%
7/34 • Number of events 10 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • Number of events 5 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
20.6%
7/34 • Number of events 15 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
|
Vascular disorders
Hot flashes
|
39.4%
13/33 • Number of events 23 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
20.6%
7/34 • Number of events 10 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
6/33 • Number of events 7 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
2.9%
1/34 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.1%
4/33 • Number of events 4 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
2.9%
1/34 • Number of events 1 • AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER