Trial Outcomes & Findings for Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer (NCT NCT00670982)

Last Updated: 2013-05-13

Results Overview

Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

1 year

Results posted on

2013-05-13

Participant Flow

Patients were enrolled between May 2008 and March 2010.

Participant milestones

Participant milestones
Measure	First Line Treatment Patients with no prior therapy for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every 2 weeks and vinorelbine(25mg/m2) intravenously once per week, and trastuzumab (4 mg/kg) intravenously once per week	Second Line Treatment Patients with 1 prior line for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every two weeks, vinorelbine (25mg/m2) intravenously once per week, and trastuzumab(4 mg/kg) intravenously once per week.
Overall Study STARTED	22	7
Overall Study COMPLETED	22	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Line Treatment n=22 Participants Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week	Second Line Treatment n=7 Participants Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	7 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	51.5 years STANDARD_DEVIATION 8 • n=5 Participants	46.7 years STANDARD_DEVIATION 6.9 • n=7 Participants	50.3 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	7 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	7 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: What percentage of patients were still on study and without progression at one year

Outcome measures

Outcome measures
Measure	First Line Treatment n=22 Participants Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week	Second Line Treatment n=7 Participants Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.	36 percentage of participants Interval 17.0 to 59.0	29 percentage of participants Interval 4.0 to 71.0

SECONDARY outcome

Timeframe: 1 year

Population: Confirmed objective response rate

Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and assessed by computed tomography.Complete response (CR), disappearance of all target and non-target lesions; partial response (PR), \>/=30% decrease in the sum of longest dimensions of target lesions; objective response rate = CR + PR.

Outcome measures

Outcome measures
Measure	First Line Treatment n=22 Participants Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week	Second Line Treatment n=7 Participants Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
Objective Response Rate	73 percentage of participants	71 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Median time from registration to progression of disease

Median progression free survival measured in months

Outcome measures

Outcome measures
Measure	First Line Treatment n=22 Participants Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week	Second Line Treatment n=7 Participants Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
Progression-free Survival	9.9 months Interval 1.6 to 22.3	7.8 months Interval 3.5 to 22.0

Adverse Events

All Study Participants

Serious events: 9 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Study Participants n=29 participants at risk All participants received the same study treatment, so cumulative adverse events are reported here.
Gastrointestinal disorders Abdominal Pain	3.4% 1/29 • Number of events 1 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Vascular disorders Deep Vein Thrombosis	3.4% 1/29 • Number of events 1 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Vascular disorders Cerebrovascular Ischemia	3.4% 1/29 • Number of events 1 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Neutropenia	17.2% 5/29 • Number of events 9 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Perforated Appendix	3.4% 1/29 • Number of events 1 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Surgical and medical procedures Surgical Intervention	3.4% 1/29 • Number of events 1 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Eye disorders Cataracts	3.4% 1/29 • Number of events 1 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.

Other adverse events

Other adverse events
Measure	All Study Participants n=29 participants at risk All participants received the same study treatment, so cumulative adverse events are reported here.
Nervous system disorders Throat/pharynx/larynx-pain	10.3% 3/29 • Number of events 4 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Abdominal Pain	17.2% 5/29 • Number of events 8 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Alkaline Phosphatase	20.7% 6/29 • Number of events 23 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Allergic Reaction	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Skin and subcutaneous tissue disorders Alopecia	24.1% 7/29 • Number of events 39 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Hepatobiliary disorders ALT-SPGT or AST-SGOT	79.3% 23/29 • Number of events 130 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Anorexia	31.0% 9/29 • Number of events 20 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Musculoskeletal and connective tissue disorders Bone-pain	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Bleeding	20.7% 6/29 • Number of events 10 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Eye disorders Cataract	17.2% 5/29 • Number of events 6 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Musculoskeletal and connective tissue disorders Chest wall-pain	6.9% 2/29 • Number of events 4 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Constipation	51.7% 15/29 • Number of events 48 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Respiratory, thoracic and mediastinal disorders Cough	20.7% 6/29 • Number of events 14 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Dehydration	10.3% 3/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Psychiatric disorders Depression	6.9% 2/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Diarrhea w/o prior colostomy	48.3% 14/29 • Number of events 38 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Nervous system disorders Dizziness	6.9% 2/29 • Number of events 4 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Skin and subcutaneous tissue disorders Dry Skin	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Dyspnoea	17.2% 5/29 • Number of events 8 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Musculoskeletal and connective tissue disorders Extremity-limb-pain	27.6% 8/29 • Number of events 14 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Fatigue	93.1% 27/29 • Number of events 164 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Febrile Neutropenia	20.7% 6/29 • Number of events 8 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Fever without Neutropenia	44.8% 13/29 • Number of events 26 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders GI-other	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Nervous system disorders Head/headache	51.7% 15/29 • Number of events 25 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Hemoglobin	93.1% 27/29 • Number of events 226 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Metabolism and nutrition disorders Hypercalcemia	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Endocrine disorders Hyperglycemia	48.3% 14/29 • Number of events 43 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Metabolism and nutrition disorders Hypernatremia	6.9% 2/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Hypertension	37.9% 11/29 • Number of events 56 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Metabolism and nutrition disorders Hypoalbuminemia	10.3% 3/29 • Number of events 5 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Metabolism and nutrition disorders Hypocalcemia	20.7% 6/29 • Number of events 17 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Metabolism and nutrition disorders Hypokalemia	13.8% 4/29 • Number of events 9 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Metabolism and nutrition disorders Hyponatremia	20.7% 6/29 • Number of events 6 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Infections and infestations Infection	24.1% 7/29 • Number of events 15 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Insomnia	17.2% 5/29 • Number of events 8 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Musculoskeletal and connective tissue disorders Joint-pain	6.9% 2/29 • Number of events 4 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Leukocytes	82.8% 24/29 • Number of events 144 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Lymphopenia	10.3% 3/29 • Number of events 4 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Metabolism and nutrition disorders Metabolic/Laboratory-other	13.8% 4/29 • Number of events 6 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Infections and infestations Muco/stomatitis	34.5% 10/29 • Number of events 12 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Musculoskeletal and connective tissue disorders Muscle-pain	20.7% 6/29 • Number of events 9 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Nasal cavity/paranasal sinus reaction	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Nausea	51.7% 15/29 • Number of events 52 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Nervous system disorders Neurologic-other	10.3% 3/29 • Number of events 5 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Nervous system disorders Neuropathy-motor	27.6% 8/29 • Number of events 8 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Nervous system disorders Neuropathy-sensory	55.2% 16/29 • Number of events 71 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Neutrophils	96.6% 28/29 • Number of events 201 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Nose-hemorrhage	55.2% 16/29 • Number of events 49 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Eye disorders Ocular	6.9% 2/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Oral cavity-hemorrhage	6.9% 2/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Nervous system disorders Pain-other	6.9% 2/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Blood and lymphatic system disorders Platelets	10.3% 3/29 • Number of events 4 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Renal and urinary disorders Proteinuria	20.7% 6/29 • Number of events 24 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Skin and subcutaneous tissue disorders Pruitus/itching	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Skin and subcutaneous tissue disorders Rash	10.3% 3/29 • Number of events 4 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Rigors	13.8% 4/29 • Number of events 5 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Taste disturbance	6.9% 2/29 • Number of events 2 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Ear and labyrinth disorders Tinnitus	6.9% 2/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders Voice changes /dysarthria	17.2% 5/29 • Number of events 9 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
Gastrointestinal disorders Vomiting	34.5% 10/29 • Number of events 14 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders weight-loss	10.3% 3/29 • Number of events 5 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.
General disorders wound-non infectious	6.9% 2/29 • Number of events 3 • 3 years Since all patients received the same study treatment, all adverse events were collected and reported together.

Additional Information

Harold J. Burstein, MD

Dana-Farber Cancer Institute

Phone: 617-632-2335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place