Trial Outcomes & Findings for Chemotherapy & Bevacizumab for Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-Negative Stage II/III Breast Cancer (NCT NCT00679029)
NCT ID: NCT00679029
Last Updated: 2023-12-11
Results Overview
This outcome is to measure the feasibility of the of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting in women with stage II and III breast cancer that does not over-express human epidermal growth factor receptor 2 (HER 2)/neu
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
through study completion, an average of 10 months
Results posted on
2023-12-11
Participant Flow
Participant milestones
| Measure |
Chemotherapy With Bevacizumab
Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 (AC) will be given every 2 weeks for cycles 1-4.
Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 (TG) will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Chemotherapy With Bevacizumab
Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 (AC) will be given every 2 weeks for cycles 1-4.
Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 (TG) will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Chemotherapy & Bevacizumab for Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-Negative Stage II/III Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=15 Participants
AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.
TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Age, Customized
>=19 years of age
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black, Not Hispanic
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 10 monthsThis outcome is to measure the feasibility of the of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting in women with stage II and III breast cancer that does not over-express human epidermal growth factor receptor 2 (HER 2)/neu
Outcome measures
| Measure |
Arm I
n=15 Participants
AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.
TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions
|
20 percentage of participants
Interval 4.33 to 48.09
|
PRIMARY outcome
Timeframe: through study completion, an average of 10 monthsAssess the safety of Avastin in the adjuvant setting particularly regarding cardiac function, wound healing and toxicity of radiation.
Outcome measures
| Measure |
Arm I
n=15 Participants
AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.
TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Count of Participants With Related Serious Adverse Events (SAEs) by NCI Common Toxicity Criteria v3.0
|
0 Participants
|
SECONDARY outcome
Timeframe: Original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 yearsOverall survival as assessed by the Kaplan and Meier method at 5 years
Outcome measures
| Measure |
Arm I
n=15 Participants
AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.
TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Overall Survival as Assessed by the Kaplan and Meier Method
|
69.1 percentage of participants
Interval 36.7 to 87.3
|
SECONDARY outcome
Timeframe: From the date of first treatment to the date of disease progression/recurrence, second cancer, or death, whichever came first: Original time frame up to 5 years from date of first treatment; study terminated at 2.5 yearsPopulation: estimated disease free survival at 5 years
Disease-free survival as assessed by the Kaplan and Meier method
Outcome measures
| Measure |
Arm I
n=15 Participants
AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.
TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Disease-free Survival
|
70 percentage of participants
Interval 38.2 to 87.6
|
Adverse Events
Arm I
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm I
n=15 participants at risk
AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.
TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Gastrointestinal disorders
colonic perforation
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Infections and infestations
Lung Infection
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
General disorders
Other, Weakness
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Other, alveolar hemorrhage
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Investigations
Platelet count decrease
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Investigations
White blood cell decreased
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Gastrointestinal disorders
Other, enteritis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Musculoskeletal and connective tissue disorders
Other, cellulitis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
Other adverse events
| Measure |
Arm I
n=15 participants at risk
AC = Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 will be given every 2 weeks for cycles 1-4.
TG = Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 will be given every 2 weeks for cycles 5-8.
Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG treatment every 2 weeks for cycles 5-7.
N=Growth factor pegfilgrastim 6 mg will be administered subcutaneously on day 1 after AC and TG treatment every 2 weeks for 8 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
3/15 • Number of events 6 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Injury, poisoning and procedural complications
dermatitis radiation
|
20.0%
3/15 • Number of events 3 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Metabolism and nutrition disorders
hyperglycemia
|
20.0%
3/15 • Number of events 3 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Gastrointestinal disorders
diarrhea
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Gastrointestinal disorders
mucositis oral
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Renal and urinary disorders
proteinuria
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Vascular disorders
hypertension
|
20.0%
3/15 • Number of events 3 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Investigations
weight gain
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Investigations
White blood cell decreased
|
20.0%
3/15 • Number of events 5 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Investigations
neutrophil count decreased
|
20.0%
3/15 • Number of events 5 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
General disorders
fatigue
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Other - respiratory infection
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Investigations
platelet count decreased
|
13.3%
2/15 • Number of events 5 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Metabolism and nutrition disorders
hypoglycemia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
6.7%
1/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Metabolism and nutrition disorders
hypoalbuminia
|
6.7%
1/15 • Number of events 2 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Metabolism and nutrition disorders
dehydration
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Musculoskeletal and connective tissue disorders
Other - cellulitis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
|
Gastrointestinal disorders
abdominal pain
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during Avastin treatment, during a post-treatment follow-up period (approximately 30 weeks) and survival (original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place