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Taxane
ABI-007 + Bevacizumab for Metastatic Breast Cancer
Phase 2
Waitlist Available
Led By Linnea Chap, MD
Research Sponsored by Premiere Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of bleeding diathesis or coagulopathy
No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying ABI-007 in combination with bevacizumab to see how well it works in treating patients with breast cancer that has spread to other parts of the body.
Who is the study for?
This trial is for women with recurrent or metastatic breast cancer who haven't had chemotherapy for the metastatic disease. They should not be pregnant, have serious heart failure, uncontrolled high blood pressure, recent major injuries or surgeries, other cancers in the last 5 years (except certain skin cancers and cervical carcinoma in situ), or known allergies to bevacizumab components.Check my eligibility
What is being tested?
The study tests ABI-007 combined with bevacizumab's effectiveness on breast cancer that has returned or spread. ABI-007 is a chemo drug that kills tumor cells by stopping their growth. Bevacizumab is an antibody that blocks tumors from growing and getting blood supply.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, increased risk of bleeding and wound healing complications due to bevacizumab, nerve damage symptoms like numbness (peripheral neuropathy), high protein levels in urine indicating kidney issues, and liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any bleeding or clotting disorders.
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My blood pressure is controlled under 150/100 mm Hg with medication.
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My cancer has returned or spread, and surgery cannot cure it.
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I have never had a severe high blood pressure crisis or brain damage from high blood pressure.
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I have not had a serious injury in the last 28 days.
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I do not have any serious, nonhealing wounds or broken bones.
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I do not have major blood vessel problems like aneurysms.
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My breast cancer diagnosis was confirmed through tissue examination.
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I do not have severe numbness or pain in my hands or feet.
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My heart functions well without severe symptoms.
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I am female.
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I am fully active or can carry out light work.
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I do not have symptoms of poor blood flow in my limbs.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival as measured by RECIST criteria at 1 and 2 years
Secondary outcome measures
Disease-free survival
Overall survival
Response rate measured every 3 courses during treatment
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Who is running the clinical trial?
Premiere OncologyLead Sponsor
Linnea Chap, MDPrincipal InvestigatorPremiere Oncology
3 Previous Clinical Trials
263 Total Patients Enrolled
2 Trials studying Breast Cancer
263 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any bleeding or clotting disorders.My blood pressure is controlled under 150/100 mm Hg with medication.I am not receiving any other treatments for breast cancer.My cancer has returned or spread, and surgery cannot cure it.I have never had a severe high blood pressure crisis or brain damage from high blood pressure.I have not had a heart attack or unstable chest pain in the last 6 months.I have not had a stroke or mini-stroke in the last 6 months.I have not had a serious injury in the last 28 days.It has been over a week since my last minor surgery or biopsy.I haven't had any major abdominal issues like fistulas, perforations, or abscesses in the last 6 months.I do not have any serious, nonhealing wounds or broken bones.It has been over 4 weeks since my last cancer treatment.I have not been treated with Abraxane or bevacizumab.My cancer can be measured by tests or scans.I do not have major blood vessel problems like aneurysms.My breast cancer diagnosis was confirmed through tissue examination.Your AST level is not more than 2 times the upper limit of normal, or not more than 5 times the upper limit of normal if you have liver involvement.I do not have severe numbness or pain in my hands or feet.I have not had chemotherapy for cancer that has spread.My heart functions well without severe symptoms.I am not taking medication to prevent infection by boosting white blood cells.I have had hormone therapy for my metastatic disease.It's been over a year since my last chemotherapy that included a taxane.I am not scheduled for any major surgeries.Your creatinine level must be below 2.0 mg/dL.Your white blood cell count is at least 1,500/mm³.It has been over 28 days since my last major surgery or open biopsy.You are not allergic to any part of bevacizumab.I haven't had any cancer in the last 5 years, except for specific non-invasive types.I am taking bisphosphonates for bone involvement.You do not have any tumors in your brain.I am female.Your bilirubin levels are within the normal range.You must have a negative pregnancy test.My cancer is not HER2 positive.Your platelet count is higher than 100,000 per cubic millimeter.I am fully active or can carry out light work.I do not have symptoms of poor blood flow in my limbs.The amount of protein in your urine is within a certain range.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What safety protocols are in place to ensure the well-being of participants undergoing this treatment?
"The safety of this particular intervention is rated as a 2, since there are data points demonstrating its security but none that verify effectiveness."
Answered by AI
Is participation in this trial still available?
"Clinicaltrials.gov does not indicate that this particular study is still recruiting patients, as its last update occurred on December 17th 2013. Despite this fact, 2600 other research protocols are actively seeking participants at the present time."
Answered by AI
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