Trial Outcomes & Findings for Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer (NCT NCT00392392)
NCT ID: NCT00392392
Last Updated: 2013-09-20
Results Overview
Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
18 months
Results posted on
2013-09-20
Participant Flow
Participant milestones
| Measure |
Nab-Paclitaxel/Bevacizumab/Trastuzumab
Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Nab-Paclitaxel/Bevacizumab/Trastuzumab
n=29 Participants
Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
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|---|---|
|
Age Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Two patients refused surgery after completing six cycles of pre-operative (neoadjuvant) therapy.
Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).
Outcome measures
| Measure |
Nab-Paclitaxel/Bevacizumab/Trastuzumab
n=27 Participants
Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
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|---|---|
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Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery
|
56 percentage of participants
|
Adverse Events
Nab-Paclitaxel/Bevacizumab/Trastuzumab
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nab-Paclitaxel/Bevacizumab/Trastuzumab
n=29 participants at risk
Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
|
|---|---|
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General disorders
Pain - Abdomen
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Infection - Skin
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Pain - Chest
|
3.4%
1/29 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Infection - Sepsis
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Nab-Paclitaxel/Bevacizumab/Trastuzumab
n=29 participants at risk
Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
65.5%
19/29 • Number of events 77
|
|
Hepatobiliary disorders
ALT
|
24.1%
7/29 • Number of events 17
|
|
Gastrointestinal disorders
Anorexia
|
17.2%
5/29 • Number of events 6
|
|
Hepatobiliary disorders
AST
|
13.8%
4/29 • Number of events 14
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
17.2%
5/29 • Number of events 5
|
|
General disorders
Rigors/Chills
|
6.9%
2/29 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
CO2
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
37.9%
11/29 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.7%
6/29 • Number of events 10
|
|
Renal and urinary disorders
Creatinine
|
6.9%
2/29 • Number of events 3
|
|
Psychiatric disorders
Mood Alteration - Depression
|
10.3%
3/29 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhea
|
55.2%
16/29 • Number of events 30
|
|
Nervous system disorders
Dizziness
|
24.1%
7/29 • Number of events 13
|
|
Blood and lymphatic system disorders
Edema
|
10.3%
3/29 • Number of events 3
|
|
General disorders
Fatigue
|
86.2%
25/29 • Number of events 118
|
|
General disorders
Fever
|
6.9%
2/29 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
29/29 • Number of events 184
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage Pulmonary - Nose
|
65.5%
19/29 • Number of events 40
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectal
|
6.9%
2/29 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage, GU
|
10.3%
3/29 • Number of events 4
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.3%
3/29 • Number of events 3
|
|
Endocrine disorders
Hot Flashes
|
13.8%
4/29 • Number of events 10
|
|
Immune system disorders
Allergic Reaction
|
6.9%
2/29 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
51.7%
15/29 • Number of events 40
|
|
Infections and infestations
Infection - Breast
|
6.9%
2/29 • Number of events 3
|
|
Infections and infestations
Infection - Sepsis
|
6.9%
2/29 • Number of events 2
|
|
Infections and infestations
Infection - Sinusitis
|
27.6%
8/29 • Number of events 18
|
|
Infections and infestations
Infection - URI
|
10.3%
3/29 • Number of events 4
|
|
Infections and infestations
Infection - UTI
|
13.8%
4/29 • Number of events 5
|
|
General disorders
Insomnia
|
27.6%
8/29 • Number of events 11
|
|
Blood and lymphatic system disorders
Leukocytes
|
89.7%
26/29 • Number of events 109
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.9%
2/29 • Number of events 15
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
10.3%
3/29 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.4%
12/29 • Number of events 41
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.3%
3/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.8%
4/29 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.9%
2/29 • Number of events 5
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
37.9%
11/29 • Number of events 31
|
|
Gastrointestinal disorders
Mucositis
|
31.0%
9/29 • Number of events 16
|
|
Gastrointestinal disorders
Nausea
|
86.2%
25/29 • Number of events 58
|
|
Nervous system disorders
Neuropathy - NOS
|
13.8%
4/29 • Number of events 15
|
|
Nervous system disorders
Neuropathy - Sensory
|
37.9%
11/29 • Number of events 33
|
|
Blood and lymphatic system disorders
Neutrophils
|
93.1%
27/29 • Number of events 116
|
|
General disorders
Pain - Abdomen
|
10.3%
3/29 • Number of events 4
|
|
General disorders
Pain - Back
|
20.7%
6/29 • Number of events 12
|
|
General disorders
Pain - Bone
|
10.3%
3/29 • Number of events 9
|
|
General disorders
Pain - Breast
|
10.3%
3/29 • Number of events 9
|
|
General disorders
Pain - Chest
|
27.6%
8/29 • Number of events 12
|
|
General disorders
Pain - Headache
|
62.1%
18/29 • Number of events 39
|
|
General disorders
Pain - Joint
|
27.6%
8/29 • Number of events 13
|
|
General disorders
Pain - Limb
|
27.6%
8/29 • Number of events 23
|
|
General disorders
Pain - Muscle
|
27.6%
8/29 • Number of events 9
|
|
General disorders
Pain - Neck
|
10.3%
3/29 • Number of events 5
|
|
General disorders
Pain - NOS
|
10.3%
3/29 • Number of events 4
|
|
General disorders
Pain - Oral
|
13.8%
4/29 • Number of events 6
|
|
General disorders
Pain - Throat
|
10.3%
3/29 • Number of events 6
|
|
General disorders
Pain - Urinary
|
13.8%
4/29 • Number of events 4
|
|
Cardiac disorders
Palpitations
|
6.9%
2/29 • Number of events 4
|
|
Vascular disorders
Phlebitis
|
6.9%
2/29 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
72.4%
21/29 • Number of events 68
|
|
Renal and urinary disorders
Proteinuria
|
24.1%
7/29 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.9%
2/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis - Radiation
|
13.8%
4/29 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.9%
2/29 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.5%
10/29 • Number of events 20
|
|
Gastrointestinal disorders
Esophagitis
|
31.0%
9/29 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
6.9%
2/29 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
13.8%
4/29 • Number of events 6
|
|
General disorders
Sweating
|
13.8%
4/29 • Number of events 6
|
|
Cardiac disorders
Tachycardia
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Taste Alteration
|
24.1%
7/29 • Number of events 19
|
|
Renal and urinary disorders
Urinary Frequency
|
6.9%
2/29 • Number of events 5
|
|
Eye disorders
Ocular - Visual Changes
|
10.3%
3/29 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
10.3%
3/29 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
27.6%
8/29 • Number of events 23
|
|
General disorders
Weakness
|
6.9%
2/29 • Number of events 3
|
|
General disorders
Weight Gain
|
6.9%
2/29 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Wound Complication
|
13.8%
4/29 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.3%
3/29 • Number of events 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER