Trial Outcomes & Findings for The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer (NCT NCT04129216)
NCT ID: NCT04129216
Last Updated: 2024-05-07
Results Overview
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
Tamoxifen Arm
for premenopausal patients
Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Letrozole Arm
for postmenopausal patients
Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Exemestane Arm
for postmenopausal patients
Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
Baseline characteristics by cohort
| Measure |
Tamoxifen Arm
n=10 Participants
for premenopausal patients
Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Letrozole Arm
n=10 Participants
for postmenopausal patients
Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Exemestane Arm
n=10 Participants
for postmenopausal patients
Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
below 55
|
7 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
7 participants
n=483 Participants
|
|
Age, Customized
55 and above
|
3 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
23 participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 participants
n=93 Participants
|
5 participants
n=4 Participants
|
4 participants
n=27 Participants
|
15 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
6 participants
n=27 Participants
|
15 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapyThis is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
Outcome measures
| Measure |
Tamoxifen Arm
n=10 Participants
for premenopausal patients
Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Letrozole Arm
n=10 Participants
for postmenopausal patients
Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Exemestane Arm
n=10 Participants
for postmenopausal patients
Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
|---|---|---|---|
|
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
|
-3.6 Change in percentage expression of ki 67
Standard Deviation 1.06
|
-5.1 Change in percentage expression of ki 67
Standard Deviation 1.82
|
-4.2 Change in percentage expression of ki 67
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline and at Time of surgery (up to 6 weeks)Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).
Outcome measures
| Measure |
Tamoxifen Arm
n=10 Participants
for premenopausal patients
Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Letrozole Arm
n=10 Participants
for postmenopausal patients
Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Exemestane Arm
n=10 Participants
for postmenopausal patients
Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
|---|---|---|---|
|
Number of Participants With Low or High Score in MammaPrint
low risk mammaprint score at baseline
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Low or High Score in MammaPrint
high risk mammaprint score at baseline
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Low or High Score in MammaPrint
low risk mammaprint score at time of surgery (up to 6 weeks)
|
7 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Low or High Score in MammaPrint
high risk mammaprint score at time of surgery (up to 6 weeks)
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and at Time of surgery (up to 6 weeks)Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)
Outcome measures
| Measure |
Tamoxifen Arm
n=10 Participants
for premenopausal patients
Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Letrozole Arm
n=10 Participants
for postmenopausal patients
Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Exemestane Arm
n=10 Participants
for postmenopausal patients
Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
|---|---|---|---|
|
Median Percent of Tissue ER Positive
Baseline median percent of tissue ER positive
|
98 percent of tissue ER positive
Interval 67.0 to 100.0
|
93 percent of tissue ER positive
Interval 76.0 to 99.0
|
95 percent of tissue ER positive
Interval 50.0 to 100.0
|
|
Median Percent of Tissue ER Positive
Time of surgery (up to 6 weeks) median percent of tissue ER positive
|
95 percent of tissue ER positive
Interval 90.0 to 95.0
|
95 percent of tissue ER positive
Interval 60.0 to 97.0
|
95 percent of tissue ER positive
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and at Time of surgery (up to 6 weeks)Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC)
Outcome measures
| Measure |
Tamoxifen Arm
n=10 Participants
for premenopausal patients
Tamoxifen Citrate: 10mg administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Letrozole Arm
n=10 Participants
for postmenopausal patients
Letrozole: 2.5mg is administered daily. Patients take this drug for 2-6 weeks
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
Exemestane Arm
n=10 Participants
for postmenopausal patients
Exemestane: 25mg is administered daily. Patients take this drug for 2-6 weeks.
Blueprint: studies the genomics of the tumor and tumor behavior
Mammaprint: studies the genomics of the tumor
|
|---|---|---|---|
|
Median Percent of Tissue PR Positive
Baseline median percent of tissue PR positive
|
97 percent of tissue PR positive
Interval 67.0 to 100.0
|
33 percent of tissue PR positive
Interval 0.0 to 95.0
|
83 percent of tissue PR positive
Interval 0.0 to 100.0
|
|
Median Percent of Tissue PR Positive
Time of surgery (up to 6 weeks) median percent of tissue PR positive
|
90 percent of tissue PR positive
Interval 75.0 to 95.0
|
0 percent of tissue PR positive
Interval 0.0 to 71.0
|
7 percent of tissue PR positive
Interval 0.0 to 35.0
|
Adverse Events
Tamoxifen Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Letrozole Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exemestane Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place