Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-28 @ 5:57 PM
Study NCT ID:
NCT01934335
Status:
TERMINATED
Last Update Posted:
2021-11-01
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C452423', 'term': 'vandetanib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ronald-weigel@uiowa.edu', 'phone': '319-353-7474', 'title': 'Ronald Weigel, MD, PhD', 'organization': 'Holden Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Vandetanib', 'description': 'Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery\n\nVandetanib', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, PO, q day for 7-14 days prior to surgery.\n\nPlacebo', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchy eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery\n\nVandetanib'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, PO, q day for 7-14 days prior to surgery.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for Ki-67.', 'unitOfMeasure': 'percentage of positivity for Ki-67.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '10 subjects took study drug and completed surgery'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery\n\nVandetanib'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, PO, q day for 7-14 days prior to surgery.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for TUNEL.', 'unitOfMeasure': 'percentage of for positivity for TUNEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '10 subjects took study drug and completed surgery'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vandetanib', 'description': 'Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery\n\nVandetanib'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, PO, q day for 7-14 days prior to surgery.\n\nPlacebo'}], 'classes': [{'title': 'Ki-67', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'TUNEL', 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Results will be stratified by RET gene expression, a negative prognostic indicator in breast cancer, to demonstrate that RET is a marker of response.', 'unitOfMeasure': 'percent change of RET positive samples', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 patients that got the study drug and completed surgery by RET expression were analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vandetanib', 'description': 'Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery\n\nVandetanib'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, PO, q day for 7-14 days prior to surgery.\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vandetanib', 'description': 'Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery\n\nVandetanib'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo, PO, q day for 7-14 days prior to surgery.\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'groupId': 'BG000', 'lowerLimit': '35.5', 'upperLimit': '71.1'}, {'value': '62.9', 'groupId': 'BG001', 'lowerLimit': '45.4', 'upperLimit': '72.5'}, {'value': '58.8', 'groupId': 'BG002', 'lowerLimit': '35.5', 'upperLimit': '72.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects who have a core biopsy of the breast which demonstrates invasive breast cancer and require surgical excision of the lesion are eligible for inclusion in the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-05', 'size': 410773, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-27T14:55', 'hasProtocol': True}, {'date': '2018-09-04', 'size': 245729, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-27T14:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Drugs unavailable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-01', 'studyFirstSubmitDate': '2013-08-29', 'resultsFirstSubmitDate': '2021-05-13', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-01', 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment', 'timeFrame': '2 weeks', 'description': 'Results will be stratified by RET gene expression, a negative prognostic indicator in breast cancer, to demonstrate that RET is a marker of response.'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment', 'timeFrame': '2 weeks', 'description': 'Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for Ki-67.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment', 'timeFrame': '2 weeks', 'description': 'Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for TUNEL.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer, TKI, tyrosine kinase inhibitor, vandetanib, Ki-67'], 'conditions': ['Invasive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to examine whether treatment with vandetanib has an effect on the tumor cells in breast cancer by examining tissue markers.', 'detailedDescription': 'The purpose of this research study is to test whether vandetanib has an effect on tumor growth markers. Vandetanib is not approved by the FDA for use in treating breast cancer. This study will compare vandetanib to a placebo.\n\nThe proposed study is designed to determine the change in Ki-67 expression on paired breast cancer samples obtained before and after treatment with vandetanib. Other tumor markers including RET, TUNEL and phosphorylation specific levels of ERK1/2, AKT and mTOR will also be assessed on the paired samples.\n\nThose who have a core biopsy of the breast which demonstrates invasive breast cancer and requires surgical excision of the lesion will be eligible for inclusion in the study. The tyrosine kinase inhibitor, vandetanib 300 mg, will be given once a day for 7-14 days prior to surgery. Following surgery, tissue markers would be analyzed on each of the paired samples, allowing for rapid assessment of in vivo response to TKI treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with core breast biopsy that, on pathology review, demonstrates invasive breast cancer and are determined to need surgical excision of the lesion. All subtypes of invasive breast cancer will be enrolled. Core biopsy specimens of enrolled patients will be stained for RET by immunohistochemistry and scored, however, patients will not be excluded according to RET expression.\n* Female gender\n* Age \\>/= 18 years of age\n* ECOG performance status \\</= 2\n* Life expectancy of greater than 6 months\n* Ability and willingness to provide informed consent to participate in study\n\nExclusion Criteria:\n\n* Prolonged QT interval (QTc \\> 480 milliseconds) on screening EKG or congenital long QT syndrome\n* Any concomitant medications that are known to be associated with Torsades de Pointes or QT elongation (see appendix 2).\n* Hypertension not controlled by medical therapy (systolic BP greater than 160 millimeters of mercury \\[mmHg\\] or diastolic blood pressure great than 100 mmHg).\n* Patients taking metformin or digoxin.\n* History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication are permitted.\n* Significant cardiac event (e.g., myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 12 weeks, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.\n* Serum calcium or magnesium outside the institutional range of normal.\n* Serum Potassium \\< 4.0 mmol/L or above 5.0 mmol/L\n* Creatinine clearance \\< 50 ml/min\n* PT \\> 12 seconds or PTT \\> 31 seconds\n* Platelet count of \\< 100,000\n* Serum bilirubin greater than 1.5 mg/dl\n* Alanine aminotransferase (ALT) \\> 50 U/L, aspartate aminotransferase (AST) \\> 65 U/L, or alkaline phosphatase (ALP) \\> 250 U/L\n* Any cytotoxic treatments, such as neoadjuvant chemotherapy, planned before subsequent surgical procedure.\n* Previous exposure to Vandetanib\n* Previous enrollment or randomization in this study\n* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and staff at UIHC).\n* Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.\n* Patients who have received prior surgical site radiation.\n* Patients on CYP3A4 inhibitors or inducers (see appendix 1).\n* Inability to test core biopsy for study markers\n* Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential.)'}, 'identificationModule': {'nctId': 'NCT01934335', 'briefTitle': 'Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Effect of Vandetanib on Cellular Markers of Proliferation and Apoptosis in Invasive Breast Cancer', 'orgStudyIdInfo': {'id': '201301763'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vandetanib', 'description': 'Vandetanib, 300 mg, PO, q day for 7-14 days prior to surgery', 'interventionNames': ['Drug: Vandetanib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, PO, q day for 7-14 days prior to surgery.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vandetanib', 'type': 'DRUG', 'otherNames': ['ZD6474'], 'armGroupLabels': ['Vandetanib']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Ronal Weigel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ronald Weigel', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ronald Weigel', 'investigatorAffiliation': 'University of Iowa'}}}}