Trial Outcomes & Findings for Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer (NCT NCT00546156)
NCT ID: NCT00546156
Last Updated: 2021-05-18
Results Overview
Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
3 Years
Results posted on
2021-05-18
Participant Flow
Study was activated on 10/17/2007 and Closed to accrual on 7/1/2011.
Participant milestones
| Measure |
HR+, HER2-
Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
|
Triple Negative Breast Cancer Cohort
Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
20
|
|
Overall Study
COMPLETED
|
70
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer
Baseline characteristics by cohort
| Measure |
HR+, HER2-
n=84 Participants
Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
|
Triple Negative Breast Cancer Cohort
n=20 Participants
Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
n=99 Participants
|
47.5 years
n=107 Participants
|
47.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=99 Participants
|
20 participants
n=107 Participants
|
104 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 YearsPopulation: Participants who met all study eligibility criteria and signed informed consent.
Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery
Outcome measures
| Measure |
HR+, HER2-
n=84 Participants
Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
|
Triple Negative Breast Cancer Cohort
n=20 Participants
Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
|
|---|---|---|
|
Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.
|
8 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: This represents the number of patients with paired IFP measurements from day 0 and day 14
To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure
Outcome measures
| Measure |
HR+, HER2-
n=52 Participants
Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
|
Triple Negative Breast Cancer Cohort
n=13 Participants
Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
|
|---|---|---|
|
Decrease in Interstitial Fluid Pressure.
|
0.70 mm Hg
Interval 0.37 to 1.32
|
1.04 mm Hg
Interval 0.69 to 1.55
|
Adverse Events
All Study Participants
Serious events: 4 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Study Participants
n=104 participants at risk
Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.96%
1/104 • Number of events 1 • 4 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
2/104 • Number of events 2 • 4 years
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.96%
1/104 • Number of events 1 • 4 years
|
|
General disorders
paranasal sinus reaction
|
0.96%
1/104 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
All Study Participants
n=104 participants at risk
Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
|
|---|---|
|
Hepatobiliary disorders
ALT-SGPT
|
46.2%
48/104 • Number of events 84 • 4 years
|
|
Hepatobiliary disorders
AST-SGOT
|
46.2%
48/104 • Number of events 120 • 4 years
|
|
Gastrointestinal disorders
Abdomen-pain
|
9.6%
10/104 • Number of events 16 • 4 years
|
|
Investigations
Alkaline Phosphatase
|
34.6%
36/104 • Number of events 87 • 4 years
|
|
Immune system disorders
Allergic Reaction
|
9.6%
10/104 • Number of events 10 • 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.5%
39/104 • Number of events 179 • 4 years
|
|
Gastrointestinal disorders
Anorexia
|
19.2%
20/104 • Number of events 40 • 4 years
|
|
Psychiatric disorders
Anxiety
|
17.3%
18/104 • Number of events 32 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back-pain
|
21.2%
22/104 • Number of events 27 • 4 years
|
|
Metabolism and nutrition disorders
Bicarbonate
|
18.3%
19/104 • Number of events 41 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone-pain
|
15.4%
16/104 • Number of events 27 • 4 years
|
|
Gastrointestinal disorders
constipation
|
45.2%
47/104 • Number of events 89 • 4 years
|
|
General disorders
Constitutional-other
|
5.8%
6/104 • Number of events 7 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
26/104 • Number of events 59 • 4 years
|
|
Renal and urinary disorders
Creatinine
|
32.7%
34/104 • Number of events 115 • 4 years
|
|
Psychiatric disorders
Depression
|
5.8%
6/104 • Number of events 9 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
32.7%
34/104 • Number of events 65 • 4 years
|
|
Nervous system disorders
Dizziness
|
8.7%
9/104 • Number of events 11 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.7%
9/104 • Number of events 13 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
20.2%
21/104 • Number of events 45 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.2%
21/104 • Number of events 47 • 4 years
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
6.7%
7/104 • Number of events 8 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb-pain
|
12.5%
13/104 • Number of events 18 • 4 years
|
|
General disorders
Fatigue
|
87.5%
91/104 • Number of events 367 • 4 years
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
5.8%
6/104 • Number of events 10 • 4 years
|
|
General disorders
fever w/o neutropenia
|
21.2%
22/104 • Number of events 35 • 4 years
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.7%
8/104 • Number of events 13 • 4 years
|
|
Gastrointestinal disorders
GI-other
|
19.2%
20/104 • Number of events 34 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
5.8%
6/104 • Number of events 12 • 4 years
|
|
Nervous system disorders
Headache
|
54.8%
57/104 • Number of events 129 • 4 years
|
|
Blood and lymphatic system disorders
Hematologic-other
|
36.5%
38/104 • Number of events 194 • 4 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
82.7%
86/104 • Number of events 387 • 4 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.5%
12/104 • Number of events 29 • 4 years
|
|
Endocrine disorders
Hot flashes
|
14.4%
15/104 • Number of events 29 • 4 years
|
|
Endocrine disorders
Hyperglycemia
|
76.0%
79/104 • Number of events 304 • 4 years
|
|
Vascular disorders
Hypertension
|
26.0%
27/104 • Number of events 59 • 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
7/104 • Number of events 18 • 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
13/104 • Number of events 24 • 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
7/104 • Number of events 8 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.6%
11/104 • Number of events 18 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Infection Gr0-2 neut-upper airway
|
9.6%
10/104 • Number of events 15 • 4 years
|
|
Infections and infestations
Infection-other
|
6.7%
7/104 • Number of events 8 • 4 years
|
|
General disorders
Insomnia
|
18.3%
19/104 • Number of events 35 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint-pain
|
29.8%
31/104 • Number of events 60 • 4 years
|
|
Blood and lymphatic system disorders
Leukocytes
|
23.1%
24/104 • Number of events 39 • 4 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
53.8%
56/104 • Number of events 182 • 4 years
|
|
Metabolism and nutrition disorders
Metabolic/laboratory-other
|
35.6%
37/104 • Number of events 123 • 4 years
|
|
Infections and infestations
Muco/stomatitis (symptom) oral cavity
|
22.1%
23/104 • Number of events 49 • 4 years
|
|
Infections and infestations
Muco/stomatitis by exam-oral cavity
|
17.3%
18/104 • Number of events 28 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle-pain
|
51.0%
53/104 • Number of events 96 • 4 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
8.7%
9/104 • Number of events 19 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
73.1%
76/104 • Number of events 197 • 4 years
|
|
Nervous system disorders
Neuropathy-motor
|
8.7%
9/104 • Number of events 11 • 4 years
|
|
Skin and subcutaneous tissue disorders
Neuropathy-sensory
|
61.5%
64/104 • Number of events 150 • 4 years
|
|
Eye disorders
Neutrophils
|
19.2%
20/104 • Number of events 32 • 4 years
|
|
Blood and lymphatic system disorders
Nose-hemorrhage
|
31.7%
33/104 • Number of events 68 • 4 years
|
|
General disorders
Oral cavity-pain
|
5.8%
6/104 • Number of events 8 • 4 years
|
|
General disorders
Pain-other
|
26.0%
27/104 • Number of events 41 • 4 years
|
|
Blood and lymphatic system disorders
Platelets
|
28.8%
30/104 • Number of events 54 • 4 years
|
|
Renal and urinary disorders
Proteinuria
|
28.8%
30/104 • Number of events 53 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Upper Respiratory-other
|
18.3%
19/104 • Number of events 36 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
24.0%
25/104 • Number of events 36 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Rigors/chills
|
5.8%
6/104 • Number of events 7 • 4 years
|
|
Vascular disorders
Skin-other
|
7.7%
8/104 • Number of events 13 • 4 years
|
|
Skin and subcutaneous tissue disorders
Sweating
|
5.8%
6/104 • Number of events 9 • 4 years
|
|
General disorders
Taste disturbance
|
5.8%
6/104 • Number of events 7 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Throat/pharynx/larynx-pain
|
28.8%
30/104 • Number of events 44 • 4 years
|
|
General disorders
Voice changes/dysarthria
|
14.4%
15/104 • Number of events 32 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
25/104 • Number of events 29 • 4 years
|
|
General disorders
Weight loss
|
6.7%
7/104 • Number of events 17 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place