Trial Outcomes & Findings for Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer (NCT NCT00217399)
NCT ID: NCT00217399
Last Updated: 2014-05-28
Results Overview
Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking. A patient has clinical benefit from treatment if CR + PR + SD \> 24 weeks.
COMPLETED
PHASE1/PHASE2
35 participants
24 weeks
2014-05-28
Participant Flow
Subjects were recruited from 22-Sep-2005 through 01-Jul-2009
Participant milestones
| Measure |
Sorafenib and Anastrozole
A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib and Anastrozole
n=35 Participants
A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Female patients with advanced or metastatic breast cancer. The protocol was initiated with intention to treat every patient enrolled with a sorafenib and anastrozole combination.
Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking. A patient has clinical benefit from treatment if CR + PR + SD \> 24 weeks.
Outcome measures
| Measure |
Sorafenib and Anastrozole
n=35 Participants
All patients receive sorafenib and anastrozole.
|
|---|---|
|
Complete Response + Partial Response + Stable Disease > 24 Weeks
|
35 participants
Interval 20.0 to 25.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All 35 patients enrolled in the study were assessed for adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0.
Number of patients treated with the sorafenib / anastrozole combination who experienced Grade 1-4 adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0
Outcome measures
| Measure |
Sorafenib and Anastrozole
n=35 Participants
All patients receive sorafenib and anastrozole.
|
|---|---|
|
Number of Participants With Adverse Events
|
35 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 14 subjects had blood specimens available for analysis
Number of participants with significant change in the following circulating tumor biomarkers, measured by flow cytometry: cluster designation (CD)146, CD133. Values were normalized by CD45 values(ie CD146+/CD45- and CD133+/CD45-).
Outcome measures
| Measure |
Sorafenib and Anastrozole
n=14 Participants
All patients receive sorafenib and anastrozole.
|
|---|---|
|
Tumor Marker Analysis
|
14 participants
|
Adverse Events
Sorafenib and Anastrozole
Serious adverse events
| Measure |
Sorafenib and Anastrozole
n=35 participants at risk
A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
|
|---|---|
|
Skin and subcutaneous tissue disorders
hand-foot syndome
|
34.3%
12/35 • Number of events 12 • 4 years
|
Other adverse events
| Measure |
Sorafenib and Anastrozole
n=35 participants at risk
A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
|
|---|---|
|
Gastrointestinal disorders
Emesis
|
40.0%
14/35 • Number of events 14 • 4 years
|
|
Skin and subcutaneous tissue disorders
acne
|
5.7%
2/35 • Number of events 2 • 4 years
|
|
Metabolism and nutrition disorders
anorexia
|
31.4%
11/35 • Number of events 11 • 4 years
|
|
Musculoskeletal and connective tissue disorders
anthralgias
|
25.7%
9/35 • Number of events 9 • 4 years
|
|
General disorders
dehydration
|
8.6%
3/35 • Number of events 3 • 4 years
|
|
Gastrointestinal disorders
diarrhea
|
62.9%
22/35 • Number of events 22 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.6%
3/35 • Number of events 3 • 4 years
|
|
Hepatobiliary disorders
elevated liver function tests
|
20.0%
7/35 • Number of events 7 • 4 years
|
|
General disorders
fatigue
|
65.7%
23/35 • Number of events 23 • 4 years
|
|
General disorders
headache
|
25.7%
9/35 • Number of events 9 • 4 years
|
|
Cardiac disorders
hypertension
|
31.4%
11/35 • Number of events 11 • 4 years
|
|
General disorders
hypophosphatemia
|
2.9%
1/35 • Number of events 1 • 4 years
|
|
Blood and lymphatic system disorders
hypotension
|
5.7%
2/35 • Number of events 2 • 4 years
|
|
Infections and infestations
infection
|
8.6%
3/35 • Number of events 3 • 4 years
|
|
Musculoskeletal and connective tissue disorders
joint function
|
11.4%
4/35 • Number of events 4 • 4 years
|
|
General disorders
mucositis
|
22.9%
8/35 • Number of events 8 • 4 years
|
|
Gastrointestinal disorders
nausea
|
60.0%
21/35 • Number of events 21 • 4 years
|
|
Blood and lymphatic system disorders
neutropenia
|
8.6%
3/35 • Number of events 3 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
2.9%
1/35 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
rash
|
48.6%
17/35 • Number of events 17 • 4 years
|
|
General disorders
rigors/chills
|
14.3%
5/35 • Number of events 5 • 4 years
|
|
Cardiac disorders
thrombosis
|
2.9%
1/35 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
urticaria
|
2.9%
1/35 • Number of events 1 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60