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Alkylating agents
A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Henderson, NV
Phase 3
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing if adding the drug bevacizumab to standard chemotherapy can help prevent HER2-negative breast cancer from returning and improve survival rates. Researchers also want to learn about any side effects from the combination of drugs.
See full description
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031100%
Headache
100%
Fatigue
83%
Lymphocyte count decreased
83%
Hemoglobin Increase
83%
Nausea
83%
Platelet count decreased
67%
Memory impairment
67%
Bicarbonate Serum-low
67%
Constipation
67%
Dizziness
67%
Gait disturbance
67%
Pyramidal Tract Dysfunction
50%
Hypoalbuminemia
50%
Hyponatremia
50%
Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)
50%
METABOLIC/LABORATORY (elevated LDH)
50%
Edema limbs
50%
Leukocytosis
50%
METABOLIC/LABORATORY (Elevated BUN)
50%
Mood Alteration
50%
Speech Impairment
33%
Muscle weakness- Whole body/generalized
33%
Diplopia
33%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Neuropathy, Sensory Legs/Toes tingling
33%
OCULAR/VISUAL (Right & Left visual field deficits)
33%
Taste Alteration
33%
Stomach pain
33%
Aspartate aminotransferase (AST) increased
33%
Hypokalemia
33%
Hypophosphatemia
33%
Alanine aminotransferase (ALT) increased
33%
Alkaline phosphatase increased
33%
Anorexia
33%
Bruising
33%
Confusion
33%
Diarrhea
33%
Gait/walking (wide based ataxic hemiparetic)
33%
Hyperglycemia
33%
Hypoglycemia
33%
METABOLIC/LABORATORY (low creatinine)
33%
METABOLIC/LABORATORY (low protein)
33%
Muscle weakness lower extremity
33%
Seizure
33%
Somnolence
17%
Hyperuricemia
17%
Infection with Normal ANC (Neck NOS), cellulitis
17%
Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum
17%
Mucositis oral
17%
Pain (Neuropathic in perineal/buttock)
17%
Hyperpigmentation (hands & knuckles)
17%
Irregular Menses
17%
Bloating
17%
Allergic rhinitis
17%
DECUBITUS Ulcer Sacrum
17%
Dehydration
17%
Heartburn
17%
Hypocalcemia
17%
Mental Status Altered
17%
METABOLIC/LABORATORY (low chloride)
17%
Obstruction GI (STOMACH-small bowel nos)
17%
Epistaxis
17%
Tremor
17%
Blood bilirubin increased
17%
Blurred vision
17%
Cholesterol high
17%
Creatinine increased
17%
Cushingoid
17%
Bump at sutura site
17%
Multiple scabs
17%
Dysphagia
17%
Edema cerebral
17%
Gait/walking Impaired mobility
17%
Gastrointestinal (sensitivity to smell)
17%
Hiccups
17%
Joint Pain
17%
METABOLIC/LABORATORY (high chloride)
17%
METABOLIC/LABORATORY (low uric acid)
17%
OCULAR SURFACE DISEASE
17%
OCULAR/VISUAL (Right homonymous hemianopsia)
17%
PAIN (BACK)
17%
Pain in extremity
17%
Pruritus
17%
Sinus bradycardia
17%
Voice alteration
17%
Weight loss
17%
Sensory loss left side
17%
Dyspnea
17%
Vomiting
17%
Hypertriglycedidemia
17%
Infection with Normal ANC (Neck NOS), herpes zoster
17%
Insomnia
17%
Neuropathy, Numbness, Right sided
17%
Sore throat
17%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Vorinostat + Bevacizumab
Phase II: Bevacizumab
Phase II: Bevacizumab + Vorinostat 400 mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Group 3: TC + bevacizumabExperimental Treatment3 Interventions
docetaxel, cyclophosphamide, and bevacizumab
Group II: Group 1: TAC then pegfilgrastimActive Control4 Interventions
docetaxel, doxorubicin, cyclophosphamide, and pegfilgrastim/filgrastim
Group III: Group 2: TCActive Control2 Interventions
docetaxel and cyclophosphamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bevacizumab
2002
Completed Phase 3
~3360
docetaxel
2015
Completed Phase 3
~7230
cyclophosphamide
1994
Completed Phase 3
~8140
Find a Location
Closest Location:US Oncology West Region Office (Horizon Ridge)· Henderson, NV
Who is running the clinical trial?
NSABP Foundation IncLead Sponsor
88 Previous Clinical Trials
138,689 Total Patients Enrolled
45 Trials studying Breast Cancer
100,717 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,579 Previous Clinical Trials
567,198 Total Patients Enrolled
96 Trials studying Breast Cancer
21,549 Patients Enrolled for Breast Cancer
US Oncology ResearchIndustry Sponsor
37 Previous Clinical Trials
15,824 Total Patients Enrolled
4 Trials studying Breast Cancer
2,633 Patients Enrolled for Breast Cancer
Norman Wolmark, MDPrincipal InvestigatorNSABP Foundation Inc
59 Previous Clinical Trials
82,104 Total Patients Enrolled
29 Trials studying Breast Cancer
67,252 Patients Enrolled for Breast Cancer