Clinical trial · Interventional
Bevacizumab and Abraxane as Second-line Therapy in Triple Negative Metastatic Breast Cancer
A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer
NCT00472693CI-TRIAL-00044585completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab, Abraxane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab and ABI-007 (Abraxane)
- description
- Bevacizumab and ABI-007 (Abraxane)
- interventionNames
- Drug: Bevacizumab, Abraxane
Primary outcomes (1)
- measure
- To determine progression-free survival among women receiving bevacizumab + ABI-007 given as second-line combination therapy for hormone receptive negative, Her-2 negative metastatic breast cancer.
- timeFrame
- Study Completion
Secondary outcomes (2)
- measure
- To determine the overall response rate to bevacizumab + ABI-007 in this study population.
- timeFrame
- Study completion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female, aged 18 years or older and able to give informed consent. * Histologically- or cytologically-proven adenocarcinoma of the breast at time of first diagnosis * ECOG performance status 0 or 1 * Life expectancy \> 12 weeks * Stage IV disease and have at least one lesion measurable by standard RECIST criteria * Disease progression after at least one prior chemotherapy regimen for metastatic disease or within 12 months of adjuvant chemotherapy initiation. * All chemotherapy must be stopped \> 2 weeks before enrollment. * Primary or metastatic tumor must be negative for estrogen and progesterone receptor expression. Testing must be done in a CLIA-approved laboratory. * Primary or metastatic tumor must have 0 or 1+ staining for HER2/neu identified immunohistochemically (IHC), by an approved method using one of the standard monoclonal or polyclonal antibodies (HercepTest, cb-11, PAb1, or TAB250), or if FISH status is known, it must be negative. Testing must be done in a CLIA-approved laboratory. * Left ventricular ejection fraction must be \>= institutional lower limit of normal as determined by MUGA or echocardiogram * Patient must be able to comply with treatment and follow-up procedures: * Adequate bone marrow, liver and renal function; Absolute neutrophil count \>= 1500/mm3; Hemoglobin \>= 10 g/dl; Platelet count \>= 100,000/mm3; Creatinine \<= 2.0; PTT and either INR or PT \< 1.5x normal; Total bilirubin \<= 1.5 X upper limit of normal; AST, ALT, and alkaline phosphatase \<= 2 X upper limit of normal (or \<= 5X upper limit of normal if known liver metastases) * If female is of childbearing potential, pregnancy test must be negative and patient must be willing to use effective contraception while on treatment and for at least 3 months after the last dose of study medication Exclusion Criteria: * Prior treatment with VEGF targeted therapy * Prior taxane therapy for metastatic disease or for adjuvant therapy within the previous 12 months * History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma skin cancers * Known CNS disease * Inadequately controlled hypertension (defined as systolic blood pressure\>150 and/or diastolic blood pressure\>100 mmHg on antihypertensive medications) * Any prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to study enrollment * History of stroke or transient ischemic attack within 6 months prior to study enrollment * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) * Symptomatic peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment * Serious, non-healing wound, ulcer or bone fracture * Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio \>1.0 at screening OR Urine dipstick for proteinuria \>2+ (patients discovered to have \>2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \<1g of protein in 24 hours to be eligible) * Patients with active infection * Women who are pregnant or lactating * Radiation therapy within 3 weeks of study entry * Patients with hypersensitivity to ABI-007, Chinese hamster ovary cell products, or other recombinant human antibodies * Baseline neuropathy \> grade 2 * Participation in an investigational study of an antineoplastic agent within 4 weeks of first infusion of this study.
References
Publications (0)
Data not yet available
No reference posted for this study.