Trial Outcomes & Findings for A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide (NCT NCT03004534)
NCT ID: NCT03004534
Last Updated: 2020-04-03
Results Overview
Androgen Receptor (AR) was assessed on the collected samples.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
36 participants
Primary outcome timeframe
1 year, 6 months
Results posted on
2020-04-03
Participant Flow
The screening period starts with registration (which is informed consent signature) and ends when the patient is enrolled (following eligibility central review confirmation by TRIO) or screen failed.
Participant milestones
| Measure |
Presurgical Molecular Assessment
Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.
darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.
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|---|---|
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Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
Baseline characteristics by cohort
| Measure |
Presurgical Molecular Assessment
n=36 Participants
Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.
darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.
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|---|---|
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Age, Continuous
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61.5 years
n=99 Participants
|
|
Age, Customized
Adults (18-64 years)
|
20 Participants
n=99 Participants
|
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Age, Customized
Adults (65-84 years)
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=99 Participants
|
|
Menopausal Status
Postmenopausal
|
27 Participants
n=99 Participants
|
|
Menopausal Status
Premenopausal
|
9 Participants
n=99 Participants
|
|
Breast Cancer Sub-Type
Triple-negative
|
7 Participants
n=99 Participants
|
|
Breast Cancer Sub-Type
HR+/HER2 negative
|
20 Participants
n=99 Participants
|
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Breast Cancer Sub-Type
HER2 positive
|
9 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 0
|
35 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 1
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 year, 6 monthsPopulation: 36 patients were enrolled, however 34 patients were evaluable based on the molecular criteria: Adequacy (evaluated by the central laboratory) for molecular assessment of the tumor tissue collected before and after the protocol treatment initiation. Expression levels were evaluated by microarray using the patient's RNA.
Androgen Receptor (AR) was assessed on the collected samples.
Outcome measures
| Measure |
Presurgical Molecular Assessment
n=34 Participants
Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.
darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.
|
|---|---|
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Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.
Androgen Receptor - Up
|
7 Participants
|
|
Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.
Androgen Receptor - Unchanged
|
12 Participants
|
|
Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.
Androgen Receptor - Down
|
15 Participants
|
SECONDARY outcome
Timeframe: 1 year, 6 monthsThe assessment of safety will be performed for all subjects who have taken at least one tablet of darolutamide (defined as the "safety population")
Outcome measures
| Measure |
Presurgical Molecular Assessment
n=36 Participants
Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.
darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.
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|---|---|
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Number of Participants With Treatment-related Adverse Events (TEAE) as Assessed by CTCAE v4.03
No. of Patients with a TEAE
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26 Participants
|
|
Number of Participants With Treatment-related Adverse Events (TEAE) as Assessed by CTCAE v4.03
No. of Patients without a TEAE
|
10 Participants
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Adverse Events
Presurgical Molecular Assessment
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Presurgical Molecular Assessment
n=36 participants at risk
Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d.
darolutamide: Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.
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|---|---|
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Gastrointestinal disorders
Constipation
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8.3%
3/36 • Number of events 3 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
3/36 • Number of events 3 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
|
|
Gastrointestinal disorders
Nasea
|
8.3%
3/36 • Number of events 3 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
|
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General disorders
Fatigue
|
22.2%
8/36 • Number of events 8 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
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Infections and infestations
Nasopharyngitis
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
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Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
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|
Injury, poisoning and procedural complications
Procedural Pain
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
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Investigations
ALAT Increase
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
|
|
Investigations
ASAT Increase
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
|
|
Renal and urinary disorders
Dysuria
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
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|
Reproductive system and breast disorders
Breast Pain
|
5.6%
2/36 • Number of events 2 • 1 year, 6 months.
The Safety population includes all patients who have taken at least one tablet of darolutamide. The following information was collected: description of event, start/stop dates, worst grade experienced (severity/intensity), seriousness, action taken on protocol treatment, and relationship to protocol treatment. The intensity of AEs were classified and recorded according to NCI CTCAE version 4.03. All adverse experiences observed by the Investigator or reported by the patient were collected.
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Additional Information
Director, Project Management
Translational Research In Oncology (TRIO)
Phone: 33 158 10 09 09
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication, abstract or presentation of the study will be made without the approval of the Study Steering Committee (SSC).
- Publication restrictions are in place
Restriction type: OTHER