Trial Outcomes & Findings for Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse (NCT NCT00462865)
NCT ID: NCT00462865
Last Updated: 2019-04-09
Results Overview
6 out of 17 patients came off study for toxicity prior to receiving all treatment. Toxicity issues of administering 6 cycles of gemcitabine, capecitabine, and Avastin and one year of consolidation of Avastin in women with breast cancer previously treated with neoadjuvant chemotherapy that lead to patients being taken off study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
1 year
Results posted on
2019-04-09
Participant Flow
18 women enrolled from 3 hospitals, 17 treated
Participant milestones
| Measure |
Gemcitabine, Capectiabine, Avastin
After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gemcitabine, Capectiabine, Avastin
After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse
Baseline characteristics by cohort
| Measure |
Treatment
n=17 Participants
After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 year6 out of 17 patients came off study for toxicity prior to receiving all treatment. Toxicity issues of administering 6 cycles of gemcitabine, capecitabine, and Avastin and one year of consolidation of Avastin in women with breast cancer previously treated with neoadjuvant chemotherapy that lead to patients being taken off study.
Outcome measures
| Measure |
Gemcitabine, Capectiabine, Avastin
n=17 Participants
After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.
|
|---|---|
|
Toxicity Related to Treatment
|
6 participants
|
SECONDARY outcome
Timeframe: 6 months and again at the end of the study (1 year)Outcome measures
| Measure |
Gemcitabine, Capectiabine, Avastin
n=18 Participants
After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.
|
|---|---|
|
Number of Participants With Recurrent Disease
|
4 Participants
|
Adverse Events
Gemcitabine, Capectiabine, Avastin
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Capectiabine, Avastin
n=17 participants at risk
After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.
|
|---|---|
|
Investigations
Left ventricular dysfunction (3)
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
infection normal ANC (3)
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
pneumonia (3)
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
anxiety, distress, diarrhea, headache, dehydration, dizziness, bilateral SOB
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
Other adverse events
| Measure |
Gemcitabine, Capectiabine, Avastin
n=17 participants at risk
After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.
Doses to be administered:
Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1
Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment.
|
|---|---|
|
Investigations
abdominal distress/pain
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
agitation
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Albumin
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Alk Phos
|
29.4%
5/17 • Number of events 5 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
alopecia
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
ALT
|
52.9%
9/17 • Number of events 9 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
ANC
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
anemia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
anorexia
|
17.6%
3/17 • Number of events 3 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
anxiety/panic attack
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
arthraglias
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
AST
|
58.8%
10/17 • Number of events 10 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Bili
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
bleeding gums
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
bloat
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
bradycardia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
CA
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
constipation
|
35.3%
6/17 • Number of events 6 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
cough
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Creatinine
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
dehydration
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
diabetic issue
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
diarrhea
|
23.5%
4/17 • Number of events 4 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
dizziness
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
dry skin
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
DVT
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
dysgeuisa
|
23.5%
4/17 • Number of events 4 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
dysphagia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
edema
|
29.4%
5/17 • Number of events 5 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
epistaxis
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
erythema
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
esophagitis
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
fatigue
|
70.6%
12/17 • Number of events 12 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
fibromyalgia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
genital lesion
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
GI other
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Glucose
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hand and foot
|
41.2%
7/17 • Number of events 7 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hemmarhoids
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Hgb
|
23.5%
4/17 • Number of events 4 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hoarseness
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hot flash
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
HTN
|
41.2%
7/17 • Number of events 7 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hyperbilrubemia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hyperglycemia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hyperpigmentation
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Hyponatremia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
hypotension
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
infection normal ANC
|
23.5%
4/17 • Number of events 4 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
insomnia
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
K
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
LDH
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
left nostril pain
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
left ventricular dysfunction
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
LFTs
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
loss of vision
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Mg
|
35.3%
6/17 • Number of events 6 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
mood alteration
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
mouth sores
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
mucositis
|
23.5%
4/17 • Number of events 4 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
muscle cramps
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
nasal dryness
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
nausea
|
41.2%
7/17 • Number of events 7 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
neuropathy
|
35.3%
6/17 • Number of events 6 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
pain- muscosk
|
82.4%
14/17 • Number of events 14 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
pharyngitis
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Phos
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Plts
|
17.6%
3/17 • Number of events 3 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
proteinuria
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
pruritis
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
rash
|
17.6%
3/17 • Number of events 3 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
rectal bleed/pain
|
17.6%
3/17 • Number of events 3 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
rhinitis
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
rigor
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
scalp blisters
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
sinusitis
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
SOB
|
11.8%
2/17 • Number of events 2 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
somolence
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
tachycardia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
thrombocytopenia
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
tremor
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Uric Acid
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
Urine Protein
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
vaginitis
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
vomitting
|
29.4%
5/17 • Number of events 5 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
WBC
|
29.4%
5/17 • Number of events 5 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
wound healing delay
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
|
Investigations
wt loss
|
5.9%
1/17 • Number of events 1 • every 3 cycles then off study, for up to 1.5 years (once off study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place