Trial Outcomes & Findings for Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib (NCT NCT01466972)
NCT ID: NCT01466972
Last Updated: 2020-07-08
Results Overview
For the purpose of this study, participants who obtained a complete response (CR), partial response (PR), or stable disease (SD) at 12 weeks per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 were defined as having a clinical benefit from the treatment. An overall response rate of 20% was considered to be clinically meaningful. All participants who take at least two weeks of study drug and the non-steroidal aromatase inhibitor were evaluated for toxicity and efficacy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-07-08
Participant Flow
Participant milestones
| Measure |
Pazopanib in Combination With a NSAI
Non-randomized, open label
Pazopanib: Oral, 800mg tablet daily per cycle
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib
Baseline characteristics by cohort
| Measure |
Pazopanib in Combination With a NSAI
n=30 Participants
Non-randomized, open label
Pazopanib: Oral, 800mg tablet daily per cycle
|
|---|---|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
13 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Twenty-eight patients met the 2 weeks of treatment minimum needed to be considered evaluable for this endpoint.
For the purpose of this study, participants who obtained a complete response (CR), partial response (PR), or stable disease (SD) at 12 weeks per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 were defined as having a clinical benefit from the treatment. An overall response rate of 20% was considered to be clinically meaningful. All participants who take at least two weeks of study drug and the non-steroidal aromatase inhibitor were evaluated for toxicity and efficacy
Outcome measures
| Measure |
Pazopanib in Combination With a NSAI
n=28 Participants
Non-randomized, open label
Pazopanib: Oral, 800mg tablet daily per cycle
|
|---|---|
|
Number of Participants With Clinical Benefit (CB)
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Twenty-eight patients met the 2 weeks of treatment minimum needed to be considered evaluable for this endpoint.
Evaluate progression free survival with ongoing evaluations at 12 week intervals until progression or up to 2 years, whichever is first.
Outcome measures
| Measure |
Pazopanib in Combination With a NSAI
n=28 Participants
Non-randomized, open label
Pazopanib: Oral, 800mg tablet daily per cycle
|
|---|---|
|
Progression Free Survival
|
20 weeks
Interval 2.0 to 104.0
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Twenty-eight patients met the 2 weeks of treatment minimum needed to be considered evaluable for this endpoint.
All patients who take at least two weeks of study drug and the non-steroidal aromatase inhibitor will be evaluable for treatment-related toxicity by ongoing evaluations at 4 week intervals until progression or up to 2 years, whichever is first.
Outcome measures
| Measure |
Pazopanib in Combination With a NSAI
n=28 Participants
Non-randomized, open label
Pazopanib: Oral, 800mg tablet daily per cycle
|
|---|---|
|
Number of Participants Experiencing Any Treatment-related Adverse Events (AE)
|
26 Participants
|
Adverse Events
Pazopanib in Combination With a NSAI
Serious events: 8 serious events
Other events: 27 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pazopanib in Combination With a NSAI
n=30 participants at risk
Non-randomized, open label
Pazopanib: Oral, 800mg tablet daily per cycle
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
General disorders
Fever
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Heart Failure
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Pazopanib in Combination With a NSAI
n=30 participants at risk
Non-randomized, open label
Pazopanib: Oral, 800mg tablet daily per cycle
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
15/30 • Number of events 21 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
36.7%
11/30 • Number of events 13 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
23.3%
7/30 • Number of events 11 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
5/30 • Number of events 10 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • Number of events 7 • Up to 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
2/30 • Number of events 3 • Up to 2 years
|
|
General disorders
Fatigue
|
53.3%
16/30 • Number of events 21 • Up to 2 years
|
|
General disorders
Chills
|
10.0%
3/30 • Number of events 4 • Up to 2 years
|
|
General disorders
Fever
|
6.7%
2/30 • Number of events 3 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
6.7%
2/30 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
10/30 • Number of events 10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
6/30 • Number of events 7 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
4/30 • Number of events 5 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
3/30 • Number of events 3 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
30.0%
9/30 • Number of events 11 • Up to 2 years
|
|
Vascular disorders
Hot flashes
|
10.0%
3/30 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
9/30 • Number of events 11 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
2/30 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
2/30 • Number of events 9 • Up to 2 years
|
|
Nervous system disorders
Headache
|
16.7%
5/30 • Number of events 7 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
13.3%
4/30 • Number of events 5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
3/30 • Number of events 5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
5/30 • Number of events 9 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
4/30 • Number of events 11 • Up to 2 years
|
|
Investigations
Investigations - Other
|
13.3%
4/30 • Number of events 24 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
3/30 • Number of events 3 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
6.7%
2/30 • Number of events 9 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
6.7%
2/30 • Number of events 5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
5/30 • Number of events 5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 4 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
10.0%
3/30 • Number of events 3 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
2/30 • Number of events 3 • Up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Urinary tract pain
|
6.7%
2/30 • Number of events 2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
3/30 • Number of events 5 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
2/30 • Number of events 3 • Up to 2 years
|
Additional Information
Dr. Hope Rugo, MD
University of California, San Francisco
Phone: (415) 353-7070
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place