Trial Outcomes & Findings for A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer (NCT NCT00632541)
NCT ID: NCT00632541
Last Updated: 2018-02-14
Results Overview
The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
Results posted on
2018-02-14
Participant Flow
Participant milestones
| Measure |
Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week. 1 Cycle = 4 weeks. Imaging every third cycle.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week. 1 Cycle = 4 weeks. Imaging every third cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
Baseline Characteristics
A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Single Arm A
n=18 Participants
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
|
|---|---|
|
Age, Continuous
|
56 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=39 Participants
|
|
ECOG Performance Status
ECOG = 0
|
13 participants
n=39 Participants
|
|
ECOG Performance Status
ECOG = 1
|
5 participants
n=39 Participants
|
|
Breast Cancer Subtype
ER-/PR-/HER2-
|
8 participants
n=39 Participants
|
|
Breast Cancer Subtype
ER-/PR-/HER2+
|
1 participants
n=39 Participants
|
|
Breast Cancer Subtype
ER+/PR-/HER2-
|
4 participants
n=39 Participants
|
|
Breast Cancer Subtype
ER+/PR+/HER2-
|
3 participants
n=39 Participants
|
|
Breast Cancer Subtype
ER+/PR+/HER2 unknown
|
2 participants
n=39 Participants
|
|
Prior Chemotherapy Regimens
Prior Chemotherapy Regimens - 0
|
1 participants
n=39 Participants
|
|
Prior Chemotherapy Regimens
Prior Chemotherapy Regimens 1-2
|
17 participants
n=39 Participants
|
|
Prior Hormone Therapy
No Prior Hormone Therapy
|
9 participants
n=39 Participants
|
|
Prior Hormone Therapy
Prior Hormone Therapy
|
9 participants
n=39 Participants
|
|
Prior Radiation Therapy
No Prior Radiation Therapy
|
7 participants
n=39 Participants
|
|
Prior Radiation Therapy
Prior Radiation Therapy
|
11 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 monthsThe primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
Outcome measures
| Measure |
Single Arm A
n=18 Participants
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
Sorafenib: Sorafenib 200mg po daily
Bevacizumab: Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks
Imaging: Imaging every third cycle
|
|---|---|
|
Progression-Free Survival
|
2.8 months
Interval 1.8 to 6.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this secondary objective was not collected or analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: Data for this secondary objective was not collected or analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: Data for this secondary objective was not collected or analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Single Arm A
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm A
n=18 participants at risk
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
|
|---|---|
|
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)
|
5.6%
1/18 • Number of events 1
|
|
General disorders
DEATH NOT ASSOCIATED WITH CTCAE TERM / DISEASE PROGRESSION NOS
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Single Arm A
n=18 participants at risk
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
|
|---|---|
|
Investigations
ALKALINE PHOSPHATASE
|
5.6%
1/18 • Number of events 1
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
5.6%
1/18 • Number of events 1
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
5.6%
1/18 • Number of events 1
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
ANOREXIA
|
27.8%
5/18 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
5.6%
1/18 • Number of events 1
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
16.7%
3/18 • Number of events 4
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER (SPECIFY, __)
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
CONFUSION
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
44.4%
8/18 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
50.0%
9/18 • Number of events 10
|
|
Gastrointestinal disorders
DEHYDRATION
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
27.8%
5/18 • Number of events 7
|
|
Gastrointestinal disorders
DIARRHEA
|
33.3%
6/18 • Number of events 9
|
|
Nervous system disorders
DIZZINESS
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
33.3%
6/18 • Number of events 7
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
11.1%
2/18 • Number of events 2
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
83.3%
15/18 • Number of events 21
|
|
General disorders
FLU-LIKE SYNDROME
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
5.6%
1/18 • Number of events 1
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
5.6%
1/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
22.2%
4/18 • Number of events 5
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / RECTUM
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
5.6%
1/18 • Number of events 1
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
27.8%
5/18 • Number of events 5
|
|
Cardiac disorders
HYPERTENSION
|
83.3%
15/18 • Number of events 18
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ABDOMEN NOS
|
5.6%
1/18 • Number of events 1
|
|
General disorders
INSOMNIA
|
22.2%
4/18 • Number of events 4
|
|
Blood and lymphatic system disorders
LYMPHATICS - OTHER (SPECIFY, __)
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
22.2%
4/18 • Number of events 4
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
22.2%
4/18 • Number of events 4
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
16.7%
3/18 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER
|
5.6%
1/18 • Number of events 4
|
|
Gastrointestinal disorders
NAUSEA
|
44.4%
8/18 • Number of events 13
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
27.8%
5/18 • Number of events 7
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
11.1%
2/18 • Number of events 5
|
|
General disorders
PAIN / BACK
|
22.2%
4/18 • Number of events 5
|
|
Cardiac disorders
PAIN / CARDIAC/HEART
|
5.6%
1/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
11.1%
2/18 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
5.6%
1/18 • Number of events 3
|
|
Gastrointestinal disorders
PAIN / DENTAL/TEETH/PERIDONTAL
|
5.6%
1/18 • Number of events 1
|
|
Ear and labyrinth disorders
PAIN / EXTERNAL EAR
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
38.9%
7/18 • Number of events 8
|
|
General disorders
PAIN / HEAD/HEADACHE
|
33.3%
6/18 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
22.2%
4/18 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
5.6%
1/18 • Number of events 1
|
|
General disorders
PAIN / NECK
|
11.1%
2/18 • Number of events 3
|
|
Gastrointestinal disorders
PAIN / ORAL CAVITY
|
5.6%
1/18 • Number of events 1
|
|
General disorders
PAIN / PAIN NOS
|
5.6%
1/18 • Number of events 2
|
|
General disorders
PAIN / PELVIS
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / RECTUM
|
11.1%
2/18 • Number of events 2
|
|
General disorders
PAIN / TUMOR PAIN
|
5.6%
1/18 • Number of events 1
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
27.8%
5/18 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
5.6%
1/18 • Number of events 1
|
|
Investigations
PROTEINURIA
|
11.1%
2/18 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
22.2%
4/18 • Number of events 6
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER (SPECIFY, __)
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
11.1%
2/18 • Number of events 2
|
|
Ear and labyrinth disorders
TINNITUS
|
11.1%
2/18 • Number of events 2
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
VOMITING
|
22.2%
4/18 • Number of events 4
|
|
General disorders
WEIGHT LOSS
|
16.7%
3/18 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
WOUND COMPLICATION, NON-INFECTIOUS
|
5.6%
1/18 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place