Trial Outcomes & Findings for Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer (NCT NCT00570323)
NCT ID: NCT00570323
Last Updated: 2020-07-28
Results Overview
The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.
COMPLETED
PHASE2
72 participants
baseline (pre) to day 28 (post)
2020-07-28
Participant Flow
Participant milestones
| Measure |
Arimidex With Faslodex
Arimidex with Faslodex in postmenopausal women
Arimidex with Faslodex: Arimidex with Faslodex
|
Arimidex
Arimidex without Faslodex in postmenopausal women.
Arimidex without Faslodex: Arimidex without Faslodex
|
|---|---|---|
|
Started Treatment After Randomization
STARTED
|
36
|
36
|
|
Started Treatment After Randomization
COMPLETED
|
34
|
35
|
|
Started Treatment After Randomization
NOT COMPLETED
|
2
|
1
|
|
Complete Study After Start
STARTED
|
34
|
35
|
|
Complete Study After Start
COMPLETED
|
31
|
34
|
|
Complete Study After Start
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Arimidex With Faslodex
Arimidex with Faslodex in postmenopausal women
Arimidex with Faslodex: Arimidex with Faslodex
|
Arimidex
Arimidex without Faslodex in postmenopausal women.
Arimidex without Faslodex: Arimidex without Faslodex
|
|---|---|---|
|
Started Treatment After Randomization
Withdrawal by Subject
|
0
|
1
|
|
Started Treatment After Randomization
Protocol Violation
|
1
|
0
|
|
Started Treatment After Randomization
Physician Decision
|
1
|
0
|
|
Complete Study After Start
Lost to Follow-up
|
0
|
1
|
|
Complete Study After Start
Withdrawal by Subject
|
2
|
0
|
|
Complete Study After Start
Physician Decision
|
1
|
0
|
Baseline Characteristics
Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Arimidex With Faslodex
n=36 Participants
Arimidex with Faslodex in postmenopausal women
Arimidex with Faslodex: Arimidex with Faslodex
|
Arimidex
n=36 Participants
Arimidex without Faslodex in postmenopausal women.
Arimidex without Faslodex: Arimidex without Faslodex
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
59 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
3 Participants
n=7 Participants
|
4 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
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (pre) to day 28 (post)Population: Patients were evaluable if their baseline and day28 samples were collected and the samples werer in good quality. 30 patients were excluded from the analysis: 12 patients did not provide the samples at baseline and/or day28; another 18 patients' samples were found with no tumor.
The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.
Outcome measures
| Measure |
ARM A / Arimidex With Faslodex
n=22 Participants
Arimidex with Faslodex in postmenopausal women
Arimidex: Aromatase inhibitors
Faslodex: Hormone Receptor
|
ARM B Arimidex Without Faslodex
n=20 Participants
Arimidex without Faslodex in postmenopausal women.
Arimidex: Aromatase inhibitors
|
|---|---|---|
|
Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples
|
-1.3632 log-transformed Ki67%
Standard Deviation 0.8949
|
-1.6237 log-transformed Ki67%
Standard Deviation 2.1592
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Patients who completed the study treatment were evaluable. 7 patients who did not complete the treatment were excluded from the analysis.
Measurable lesions were examined at baseline to treatment completion.Clinical Response was defined by Solid Tumor Response Criteria (RECIST).
Outcome measures
| Measure |
ARM A / Arimidex With Faslodex
n=31 Participants
Arimidex with Faslodex in postmenopausal women
Arimidex: Aromatase inhibitors
Faslodex: Hormone Receptor
|
ARM B Arimidex Without Faslodex
n=34 Participants
Arimidex without Faslodex in postmenopausal women.
Arimidex: Aromatase inhibitors
|
|---|---|---|
|
Clinical Response
Complete response
|
4 Participants
|
5 Participants
|
|
Clinical Response
Partial response
|
18 Participants
|
19 Participants
|
|
Clinical Response
Stable disease
|
5 Participants
|
5 Participants
|
|
Clinical Response
Progression disease
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Patients who had surgery in the study were evaluable. 13 patients who did not have surgery were excluded from the analysis: 7 patients did not complete study treatment, another 6 patients did not have surgery performed.
Pathologic response was defined as no residual invasive tumor on histopathological analysis in the breast primary. Patients were assessed according to the Chevallier classification of pathologic response.
Outcome measures
| Measure |
ARM A / Arimidex With Faslodex
n=29 Participants
Arimidex with Faslodex in postmenopausal women
Arimidex: Aromatase inhibitors
Faslodex: Hormone Receptor
|
ARM B Arimidex Without Faslodex
n=30 Participants
Arimidex without Faslodex in postmenopausal women.
Arimidex: Aromatase inhibitors
|
|---|---|---|
|
Pathologic Complete Response
not pathologic response
|
28 Participants
|
28 Participants
|
|
Pathologic Complete Response
pathologic response
|
1 Participants
|
2 Participants
|
Adverse Events
Arimidex
Arimidex With Faslodex
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arimidex
n=35 participants at risk
Arimidex without Faslodex in postmenopausal women.
Arimidex without Faslodex: Arimidex without Faslodex
|
Arimidex With Faslodex
n=34 participants at risk
Arimidex with Faslodex in postmenopausal women
Arimidex with Faslodex: Arimidex with Faslodex
|
|---|---|---|
|
Nervous system disorders
Arthralgia
|
37.1%
13/35 • Number of events 14
|
20.6%
7/34 • Number of events 7
|
|
Nervous system disorders
Bone pain
|
11.4%
4/35 • Number of events 4
|
8.8%
3/34 • Number of events 3
|
|
General disorders
Fatigue
|
22.9%
8/35 • Number of events 9
|
20.6%
7/34 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.7%
2/35 • Number of events 2
|
8.8%
3/34 • Number of events 3
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Number of events 4
|
8.8%
3/34 • Number of events 3
|
|
Endocrine disorders
Hot flashes
|
45.7%
16/35 • Number of events 16
|
32.4%
11/34 • Number of events 11
|
|
General disorders
Insomnia
|
17.1%
6/35 • Number of events 6
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Number of events 3
|
14.7%
5/34 • Number of events 5
|
|
Reproductive system and breast disorders
Vaginal dryness
|
17.1%
6/35 • Number of events 6
|
2.9%
1/34 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place