Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 1:47 AM
Study NCT ID:
NCT00472693
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2007-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab and Abraxane as Second-line Therapy in Triple Negative Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'dispFirstSubmitDate': '2020-04-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2007-05-11', 'dispFirstSubmitQcDate': '2020-04-06', 'studyFirstSubmitQcDate': '2007-05-11', 'dispFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'To determine the overall response rate to bevacizumab + ABI-007 in this study population.', 'timeFrame': 'Study completion'}, {'measure': 'To determine the toxicity of bevacizumab + ABI-007 in this study population.', 'timeFrame': 'Study completion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Metastatic breast cancer', 'Second-Line Therapy', 'Triple Negative', 'Her-2 negative', 'Hormone receptor negative', 'Abraxane', 'Bevacizumab'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, aged 18 years or older and able to give informed consent.\n* Histologically- or cytologically-proven adenocarcinoma of the breast at time of first diagnosis\n* ECOG performance status 0 or 1\n* Life expectancy \\> 12 weeks\n* Stage IV disease and have at least one lesion measurable by standard RECIST criteria\n* Disease progression after at least one prior chemotherapy regimen for metastatic disease or within 12 months of adjuvant chemotherapy initiation.\n* All chemotherapy must be stopped \\> 2 weeks before enrollment.\n* Primary or metastatic tumor must be negative for estrogen and progesterone receptor expression. Testing must be done in a CLIA-approved laboratory.\n* 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.\n* Left ventricular ejection fraction must be \\>= institutional lower limit of normal as determined by MUGA or echocardiogram\n* Patient must be able to comply with treatment and follow-up procedures:\n* 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)\n* 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\n\nExclusion Criteria:\n\n* Prior treatment with VEGF targeted therapy\n* Prior taxane therapy for metastatic disease or for adjuvant therapy within the previous 12 months\n* History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma skin cancers\n* Known CNS disease\n* Inadequately controlled hypertension (defined as systolic blood pressure\\>150 and/or diastolic blood pressure\\>100 mmHg on antihypertensive medications)\n* Any prior history of hypertensive crisis or hypertensive encephalopathy\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure\n* History of myocardial infarction or unstable angina within 6 months prior to study enrollment\n* History of stroke or transient ischemic attack within 6 months prior to study enrollment\n* Significant vascular disease (e.g., aortic aneurysm, aortic dissection)\n* Symptomatic peripheral vascular disease\n* Evidence of bleeding diathesis or coagulopathy\n* 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\n* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment\n* Serious, non-healing wound, ulcer or bone fracture\n* 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)\n* Patients with active infection\n* Women who are pregnant or lactating\n* Radiation therapy within 3 weeks of study entry\n* Patients with hypersensitivity to ABI-007, Chinese hamster ovary cell products, or other recombinant human antibodies\n* Baseline neuropathy \\> grade 2\n* Participation in an investigational study of an antineoplastic agent within 4 weeks of first infusion of this study.'}, 'identificationModule': {'nctId': 'NCT00472693', 'briefTitle': 'Bevacizumab and Abraxane as Second-line Therapy in Triple Negative Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Phase II Trial of Bevacizumab and ABI-007 (Abraxane) as Second-line Therapy in Her-2 Negative, Hormone Receptor Negative Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'UPCC 02106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab and ABI-007 (Abraxane)', 'description': 'Bevacizumab and ABI-007 (Abraxane)', 'interventionNames': ['Drug: Bevacizumab, Abraxane']}], 'interventions': [{'name': 'Bevacizumab, Abraxane', 'type': 'DRUG', 'description': 'Bevacizumab, 10 mg/m2 IV days 1 and 15; ABI-007, 100 mg/m2 IV days 1, 8, 15 of each 28 day cycle. Continue treatment until disease progression, patient withdrawal or unacceptable toxicities.', 'armGroupLabels': ['Bevacizumab and ABI-007 (Abraxane)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center at University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Angela DeMichele, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center of University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}