Trial Outcomes & Findings for Bicalutamide in Treating Patients With Metastatic Breast Cancer (NCT NCT00468715)
NCT ID: NCT00468715
Last Updated: 2022-08-03
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
6 months
Results posted on
2022-08-03
Participant Flow
Participant milestones
| Measure |
Bicalutamide
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
bicalutamide
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bicalutamide in Treating Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Bicalutamide
n=28 Participants
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
bicalutamide
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
|
|---|---|
|
Age, Continuous
|
54 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Bicalutamide
n=28 Participants
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
bicalutamide
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
|
|---|---|
|
6-month Response Rate (Complete Response, Partial Response, and Stable Disease)
Stable Disease
|
9 Participants
|
|
6-month Response Rate (Complete Response, Partial Response, and Stable Disease)
Progression of Disease
|
15 Participants
|
|
6-month Response Rate (Complete Response, Partial Response, and Stable Disease)
Not Entered
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Bicalutamide
n=28 Participants
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
bicalutamide
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
|
|---|---|
|
Count of Participants With Progression-free Survival
Participants who progressed
|
22 Participants
|
|
Count of Participants With Progression-free Survival
Participants who did not progress
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearToxicity measured by CTCAE v3.0
Outcome measures
| Measure |
Bicalutamide
n=28 Participants
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
bicalutamide
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
|
|---|---|
|
Number of Participants Evaluated for Toxicity
|
28 Participants
|
Adverse Events
Bicalutamide
Serious events: 4 serious events
Other events: 28 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Bicalutamide
n=28 participants at risk
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
bicalutamide
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
10.7%
3/28 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
2/28 • 1 year
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
3.6%
1/28 • 1 year
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow, other
|
3.6%
1/28 • 1 year
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
3.6%
1/28 • 1 year
|
|
Gastrointestinal disorders
Colitis, infection
|
7.1%
2/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
2/28 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
3/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.6%
1/28 • 1 year
|
|
General disorders
Fatigue
|
3.6%
1/28 • 1 year
|
|
General disorders
Fever (in the absence of neutropenia)
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
14.3%
4/28 • 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
14.3%
4/28 • 1 year
|
|
Investigations
Lymphopenia
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
14.3%
4/28 • 1 year
|
|
Psychiatric disorders
Mood alteration - Depression
|
3.6%
1/28 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • 1 year
|
|
Gastrointestinal disorders
Pain - abdomen NOS
|
3.6%
1/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Phospate, low (hypophosphatemia)
|
14.3%
4/28 • 1 year
|
|
Investigations
Platelets
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
14.3%
4/28 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • 1 year
|
Other adverse events
| Measure |
Bicalutamide
n=28 participants at risk
This is a multicenter, open-label, phase II study to evaluate the antitumor activity and safety of bicalutamide administered orally daily to patients with ER(-)/PR(-)/AR(+) metastatic breast cancer. Eligible patients who have consented to trial participation will receive bicalutamide at a dose of 150mg PO daily.
bicalutamide
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
|
|---|---|
|
Investigations
AST, SGOT
|
35.7%
10/28 • 1 year
|
|
General disorders
Fatigue
|
32.1%
9/28 • 1 year
|
|
Investigations
ALT, SGPT
|
28.6%
8/28 • 1 year
|
|
General disorders
Edema, limb
|
28.6%
8/28 • 1 year
|
|
Vascular disorders
Hot flashes/flushes
|
25.0%
7/28 • 1 year
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
21.4%
6/28 • 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
21.4%
6/28 • 1 year
|
|
Investigations
Alkaline Phosphatase
|
17.9%
5/28 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
17.9%
5/28 • 1 year
|
|
Investigations
Leukocytes (total WBC)
|
17.9%
5/28 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
4/28 • 1 year
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
14.3%
4/28 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
14.3%
4/28 • 1 year
|
|
Nervous system disorders
Neuropathy, sensory
|
14.3%
4/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
10.7%
3/28 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
3/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.7%
3/28 • 1 year
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.7%
3/28 • 1 year
|
|
Reproductive system and breast disorders
Pain - breast
|
10.7%
3/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
10.7%
3/28 • 1 year
|
|
Investigations
Platelets
|
10.7%
3/28 • 1 year
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
7.1%
2/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28 • 1 year
|
|
Investigations
Creatinine
|
7.1%
2/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
2/28 • 1 year
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
7.1%
2/28 • 1 year
|
|
Vascular disorders
Hypertension
|
7.1%
2/28 • 1 year
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
7.1%
2/28 • 1 year
|
|
Psychiatric disorders
Mood alteration - Depression
|
7.1%
2/28 • 1 year
|
|
Eye disorders
Ocular/visual - other
|
7.1%
2/28 • 1 year
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
7.1%
2/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
7.1%
2/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
7.1%
2/28 • 1 year
|
|
General disorders
Pain - other (specify)
|
7.1%
2/28 • 1 year
|
|
Reproductive system and breast disorders
Vaginal dryness
|
7.1%
2/28 • 1 year
|
Additional Information
Dr. Tiffany Traina
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place