Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-28 @ 8:44 PM
Study NCT ID:
NCT00773695
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2008-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative 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': 'D047072', 'term': 'Aromatase Inhibitors'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI)', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Objective Pathological Complete Response, as Assessed by Clinical Assessment', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}, {'measure': 'Percentage of Participants With Type of Surgery', 'timeFrame': 'At Surgery (Between Weeks 24 and 25)', 'description': 'Percentage of participants with different surgery types (for example, Mastectomy, Tumorectomy/Breast conserving therapy (BCT), and Tumorectomy followed by mastectomy) will be reported.'}, {'measure': 'Percentage of Participants With Axillary Lymph Node Dissection Performed', 'timeFrame': 'At Surgery (Between Weeks 24 and 25)'}, {'measure': 'Pathological Tumor Size, as Assessed by Histopathological Examination', 'timeFrame': 'At Surgery (Between Weeks 24 and 25)'}, {'measure': 'Percentage of Participants With Presence of Tumor Cells Close to Resection Margin', 'timeFrame': 'At Surgery (Between Weeks 24 and 25)'}, {'measure': 'Percentage of Participants With Tumor Deposit in Other Body Parts', 'timeFrame': 'At Surgery (Between Weeks 24 and 25)'}, {'measure': 'Tumor Free Resection Margin', 'timeFrame': 'At Surgery (Between Weeks 24 and 25)'}, {'measure': 'Pathological Tumor Size as Measure Using Caliper', 'timeFrame': 'Cycles 1 to 10 (cycle length=21 days), and Week 25'}, {'measure': 'Pathological Tumor Size as Measure Using MRI', 'timeFrame': 'Baseline, Weeks 12 and 25'}, {'measure': 'Pathological Tumor Size as Measure Using Mamography', 'timeFrame': 'Baseline, Weeks 12 and 25'}, {'measure': 'Pathological Breast Tumor Size as Measure Using Ultrasound', 'timeFrame': 'Baseline, Weeks 12 and 25'}, {'measure': 'Pathological Axilla Tumor Size as Measure Using Ultrasound', 'timeFrame': 'Baseline, Weeks 12 and 25'}, {'measure': 'Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status', 'timeFrame': 'Screening, Cycles 1 to 10 (cycle length=21 days), and Week 25'}, {'measure': 'Percentage of Participants With Lymph Node Involvement', 'timeFrame': 'Cycles 1 to 10 (cycle length=21 days), and Week 25'}, {'measure': 'Percentage of Participants With Objective Tumor Response, as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'Weeks 12 and 25'}, {'measure': 'Percentage of Participants With New Lesions', 'timeFrame': 'Weeks 12 and 25'}, {'measure': 'Percentage of Participants With Molecular Changes in Protein Kinase Expression', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}, {'measure': 'Percentage of Participants With Molecular Changes in Messenger Ribonucleic Acid (mRNA)/microRNA(miRNA)', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}, {'measure': 'Percentage of Participants With Molecular Changes in Protein Expression', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}, {'measure': 'Percentage of Participants With Single Nucleotide Polymorphism (SNP) Profiles Predicting Treatment Response', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}, {'measure': 'Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Disseminated Tumor Cells in Bone Marrow', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}, {'measure': 'Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Circulating Tumor Cells in Peripheral Blood', 'timeFrame': 'Baseline up to end of study treatment (approximately 24 weeks)'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30497530', 'type': 'DERIVED', 'citation': 'Hoglander EK, Nord S, Wedge DC, Lingjaerde OC, Silwal-Pandit L, Gythfeldt HV, Vollan HKM, Fleischer T, Krohn M, Schlitchting E, Borgen E, Garred O, Holmen MM, Wist E, Naume B, Van Loo P, Borresen-Dale AL, Engebraaten O, Kristensen V. Time series analysis of neoadjuvant chemotherapy and bevacizumab-treated breast carcinomas reveals a systemic shift in genomic aberrations. Genome Med. 2018 Nov 29;10(1):92. doi: 10.1186/s13073-018-0601-y.'}, {'pmid': '28042070', 'type': 'DERIVED', 'citation': 'Reinertsen KV, Engebraaten O, Loge JH, Cvancarova M, Naume B, Wist E, Edvardsen H, Wille E, Bjoro T, Kiserud CE. Fatigue During and After Breast Cancer Therapy-A Prospective Study. J Pain Symptom Manage. 2017 Mar;53(3):551-560. doi: 10.1016/j.jpainsymman.2016.09.011. Epub 2016 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine 100 milligrams per square meter \\[mg/m\\^2\\], 5-fluorouracil 600 mg/m\\^2, and cyclophosphamide 600 mg/m\\^2\\] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine therapy (an aromatase inhibitor\\] daily for 24 weeks) with or without bevacizumab (15 milligrams per kilogram \\[mg/kg\\] as intravenous \\[IV\\] infusion every 3 weeks up 24 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (\\>=) 2.5 centimeters (cm) in size\n* Eastern Cooperative Oncology Group (ECOG)/world health organization (WHO) performance status less than or equal to (\\</=) 2\n* Normal baseline cardiac function (Left Ventricular Ejection Fraction \\[LVEF\\])\n\nExclusion Criteria:\n\n* Stage IV (metastatic) disease\n* Previous treatment for localized breast cancer less than (\\<) 24 months from diagnosis of present breast cancer\n* Other previous or current cancer except for basal cell cancer or in situ cervical cancer\n* Current or recent use of aspirin (greater than \\[\\>\\] 325 milligrams per day)\n* Clinically significant cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT00773695', 'briefTitle': 'A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negative Breast Cancers', 'orgStudyIdInfo': {'id': 'ML21744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks.', 'interventionNames': ['Drug: Epirubicine', 'Drug: 5-Fluorouracil (5FU)', 'Drug: Cyclophosphamide', 'Drug: Paclitaxel', 'Drug: Docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy and Bevacizumab', 'description': 'Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Participants will also receive concurrent treatment with bevacizumab every 3 weeks for 24 weeks.', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Epirubicine', 'Drug: 5-Fluorouracil (5FU)', 'Drug: Cyclophosphamide', 'Drug: Paclitaxel', 'Drug: Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endocrine Therapy', 'description': 'Participants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks.', 'interventionNames': ['Drug: Aromatase Inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'Endocrine Therapy and Bevacizumab', 'description': 'Participants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks.', 'interventionNames': ['Drug: Aromatase Inhibitor', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Aromatase Inhibitor', 'type': 'DRUG', 'description': 'Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.', 'armGroupLabels': ['Endocrine Therapy', 'Endocrine Therapy and Bevacizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.', 'armGroupLabels': ['Chemotherapy and Bevacizumab', 'Endocrine Therapy and Bevacizumab']}, {'name': 'Epirubicine', 'type': 'DRUG', 'description': 'Participants will receive epirubicine at a dose of 100 mg/m\\^2 as IV infusion every 3 weeks for 12 weeks.', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy and Bevacizumab']}, {'name': '5-Fluorouracil (5FU)', 'type': 'DRUG', 'description': 'Participants will receive 5FU at a dose of 600 mg/m\\^2 as IV infusion every 3 weeks for 12 weeks.', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy and Bevacizumab']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Participants will receive cyclophosphamide at a dose of 600 mg/m\\^2 as IV infusion every 3 weeks for 12 weeks.', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy and Bevacizumab']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Participants will receive paclitaxel at a dose of 80 mg/m\\^2 as IV infusion every week for 12 weeks.', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy and Bevacizumab']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Participants will receive docetaxel at a dose of 100 mg/m\\^2 as IV infusion every 3 weeks for 12 weeks.', 'armGroupLabels': ['Chemotherapy', 'Chemotherapy and Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0379', 'city': 'Oslo', 'country': 'Norway', 'facility': 'The Norvegian Radium Hospital Montebello; Dept of Oncology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevael Sykehus; Dept of Oncology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '7000', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital; Kreftavdelingen', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Norwegian Radium Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}