Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer (ABC)
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ClinicalTrials.gov Identifier: NCT00479674 |
Recruitment Status
:
Completed
First Posted
: May 28, 2007
Results First Posted
: February 18, 2015
Last Update Posted
: February 18, 2015
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Abraxane Drug: Bevacizumab Drug: Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) Metastatic Breast Cancer |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Abraxane, Carboplatin, Bevacizumab
Abraxane 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
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Drug: Abraxane
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..
Other Name: nanoparticle albumin-bound paclitaxel
Drug: Bevacizumab
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.
Other Name: Avastin
Drug: Carboplatin
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.
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- 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. [ Time Frame: 5 years ]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.
- Median Proportion Progression-free as Estimated by Kaplan-Meier Methods [ Time Frame: 5 years ]PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.
- To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers [ Time Frame: 18 months ]
- to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy [ Time Frame: 18 months ]
- to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS) [ Time Frame: 18 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
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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);
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Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN;
- Alkaline phosphatase ≤ 2.5 times ULN;
- Estimated creatinine clearance ≥ 60 mL/min.
- left ventricular ejection fraction (LVEF)≥ 50% by multigated acquisition (MUGA)/Echocardiogram;
- Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;
- Cognitive and communication skills to comply with study and/or follow-up procedures;
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No reproductive potential:
- If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.
- If post-menopausal: Amenorrhea for ≥ 12 months.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479674
United States, North Carolina | |
Presbyterian Health Care | |
Charlotte, North Carolina, United States, 28204 | |
Northeast Oncology Associates | |
Concord, North Carolina, United States, 28205 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Forsyth Regional Cancer Center | |
Winston-Salem, North Carolina, United States, 27103-3019 |
Principal Investigator: | Kimberly Blackwell, MD | Duke University |
Additional Information:
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00479674 History of Changes |
Other Study ID Numbers: |
Pro00014837 AVF3962s |
First Posted: | May 28, 2007 Key Record Dates |
Results First Posted: | February 18, 2015 |
Last Update Posted: | February 18, 2015 |
Last Verified: | January 2015 |
Keywords provided by Duke University:
Metastatic Breast Cancer Advanced Breast Cancer Hormone Receptor AND Her2/neu Negative |
Triple Negative Triple Negative Breast Cancer Stage IV or Inoperable Stage III Breast Cancer |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bevacizumab Carboplatin Albumin-Bound Paclitaxel Paclitaxel Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |