Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer
ABC
A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) Metastatic Breast Cancer
2 other identifiers
interventional
41
1 country
4
Brief Summary
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. Monoclonal antibodies including bevacizumab target vascular endothelial growth factor (VEGF) to reduce angiogenesis. We hypothesize that the previously-untested combination of weekly Abraxane® and carboplatin plus biweekly bevacizumab will lengthen time to progression without producing intolerable toxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started May 2007
Longer than P75 for phase_2 breast-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 25, 2007
CompletedFirst Posted
Study publicly available on registry
May 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
February 18, 2015
CompletedFebruary 18, 2015
January 1, 2015
6.8 years
May 25, 2007
December 9, 2014
January 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.
Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.
5 years
Secondary Outcomes (4)
Median Proportion Progression-free as Estimated by Kaplan-Meier Methods
5 years
To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers
18 months
to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy
18 months
to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS)
18 months
Study Arms (1)
Abraxane, Carboplatin, Bevacizumab
EXPERIMENTALAbraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
Interventions
100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
Eligibility Criteria
You may qualify if:
- Tissue block containing tumor to confirm metastatic breast cancer is required;
- Measurable disease according to RECIST criteria
- "Triple negative" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. "No expression" is categorized as ≤ 10% of cells staining or Allred ≤ 2;
- Aged 18 years or older;
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months;
- Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;
- ≥ 2 weeks between surgery and study enrollment (≥ 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;
- Laboratory tests performed within 14 days of study entry:
- Granulocytes ≥ 1,500/µL;
- Platelets ≥ 100,000/µL;
- Hemoglobin ≥ 9 gm/dL;
- Total bilirubin ≤ institutional upper limit of normal (ULN);
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN;
- Alkaline phosphatase ≤ 2.5 times ULN;
- Estimated creatinine clearance ≥ 60 mL/min.
- +6 more criteria
You may not qualify if:
- Pregnant or breast feeding;
- Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;
- Known hypersensitivity to any component of any study drug;
- Active infection;
- Current neuropathy ≥ grade 2;
- central nervous system (CNS) metastases as determined by head CT with contrast;
- History of bleeding within the past 6 months or active bleeding disorder;
- Serious non-healing wound, ulcer or bone fracture;
- Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;
- Inadequately controlled hypertension (defined as systolic blood pressure \< 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;
- Proteinuria (defined as urine protein: creatinine (UPC) ratio ≥ 1.0 or urine dipstick ≥ 2+.
- Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;
- Uncontrolled serious contraindicated medical condition or psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Genentech, Inc.collaborator
- Celgene Corporationcollaborator
Study Sites (4)
Presbyterian Health Care
Charlotte, North Carolina, 28204, United States
Northeast Oncology Associates
Concord, North Carolina, 28205, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, 27103-3019, United States
Related Publications (1)
Jasim SA, Farber IM, Noraldeen SAM, Bansal P, Alsaab HO, Abdullaev B, Alkhafaji AT, Alawadi AH, Hamzah HF, Mohammed BA. Incorporation of immunotherapies and nanomedicine to better normalize angiogenesis-based cancer treatment. Microvasc Res. 2024 Jul;154:104691. doi: 10.1016/j.mvr.2024.104691. Epub 2024 May 3.
PMID: 38703993DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kimberly Blackwell
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Blackwell, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2007
First Posted
May 28, 2007
Study Start
May 1, 2007
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
February 18, 2015
Results First Posted
February 18, 2015
Record last verified: 2015-01