Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks.
Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms.\nHypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.
","id":"EG000","otherNumAffected":2,"otherNumAtRisk":50,"seriousNumAffected":2,"seriousNumAtRisk":50,"title":"Letrozole + Avastin"},{"deathsNumAffected":0,"deathsNumAtRisk":25,"description":"Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms.\nHypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":25,"seriousNumAffected":0,"seriousNumAtRisk":25,"title":"Letrozole Alone"}],"frequencyThreshold":"2","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"other","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":25,"numEvents":0}],"term":"Headache"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"proteinuria 4%","organSystem":"Renal and urinary disorders","sourceVocabulary":"other","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50},{"groupId":"EG001","numAffected":0,"numAtRisk":25,"numEvents":0}],"term":"Proteinuria"}],"timeFrame":"24 weeks of active treatment"},"baselineCharacteristicsModule":{"denoms":[{"counts":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"75"}],"units":"Participants"}],"groups":[{"description":"Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks","id":"BG000","title":"Letrozole + Avastin"},{"description":"Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks","id":"BG001","title":"Letrozole Alone"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"75"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"0.5","value":"58"},{"groupId":"BG001","spread":"0.5","value":"58"},{"groupId":"BG002","spread":"0.5","value":"58"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"75"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"10"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"60"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"75"}]}],"title":"United States"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"75"}]}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Study Participant","unitOfMeasure":"Participants"}],"populationDescription":"Postmenopausal women with newly diagnosed stage 2 or 3 estrogen and/or progesterone receptor-positive, HER2-negative breast cancer were randomly assigned (2:1) between letrozole 2.5 mg PO daily plus bevacizumab 15 mg/ kg IV every 3 weeks (Let/Bev) and letrozole 2.5 mg PO daily (Let) for 24 weeks prior to definitive surgery."},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"email":"Lnabell@uabmc.edu","organization":"UAB","phone":"205 934-3061","title":"Lisle Nabell"}},"outcomeMeasuresModule":{"outcomeMeasures":[{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.7","upperLimit":"24.1","value":"11"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"14.2","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"description":"Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.","dispersionType":"95% Confidence Interval","groups":[{"description":"Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks","id":"OG000","title":"Letrozole + Avastin"},{"description":"Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks","id":"OG001","title":"Letrozole Alone"}],"paramType":"NUMBER","populationDescription":"Patients with postmenopausal hormone receptor positive breast cancer T2-4,N0-2 and M0 were randomized 2:1 to receive letrozole 2.5 mg PO daily and bevacizumab 15 mg/kg IV for 24 weeks or daily treatment with letrozole 2.5 mg PO alone (control arm).\nThe duration of each cycle was 3 weeks for a total of 24 weeks.\nThe pCR was defined as the absence of any residual invasive cancer in the resected breast specimen and lymph nodes.\nData below is representative of the raw data.","reportingStatus":"POSTED","timeFrame":"24 weeks","title":"The Percentage of Participants With Pathologic Complete Response","type":"PRIMARY","unitOfMeasure":"percentage of participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.4","upperLimit":"22","value":"10"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"20.4","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"description":"Radiographic objective response to the therapy are reported.\nRadiographic response was assessed using RECIST criteria by ultrasound or breast MRI through the study and are reported as complete radiographic response below.","dispersionType":"95% Confidence Interval","groups":[{"description":"50 evaluable patients received the combination therapy of 2.5 gm daily oral Letrozole and Avastin 15 mg/kg IV every 3 weeks for 24 weeks.
Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
","id":"OG000","title":"Letrozole + Avastin"},{"description":"25 evaluable patients received daily oral 2.5 mg letrozole as a single agent
Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks
","id":"OG001","title":"Letrozole Alone"}],"paramType":"NUMBER","populationDescription":"This was a single arm study to test the feasibility of Letrozole with Avastin in the neoadjuvant setting.","reportingStatus":"POSTED","timeFrame":"24 weeks","title":"Letrozole +Avastin","type":"SECONDARY","unitOfMeasure":"participants"}]},"participantFlowModule":{"groups":[{"description":"Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks","id":"FG000","title":"Letrozole + Avastin"},{"description":"Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks","id":"FG001","title":"Letrozole Alone"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"25"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"25"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}}},{"op":"add","path":"/documentSection","value":{"largeDocumentModule":{"largeDocs":[{"date":"2011-03-14","filename":"Prot_SAP_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":true,"label":"Study Protocol and Statistical Analysis Plan","size":556643,"typeAbbrev":"Prot_SAP","uploadDate":"2022-01-20T14:32"}]}}}],"provenance":{"from_snapshot_hash":"fa7003e0fde6aa9044a3195a7dedabaf0b972d652135295dcd2680e683612d79","materiality_event_hash":"dcde938c808194d2e3c477e21e96b0a32b6373e9c8cb21042df1993055f657b2","patch_hash":"9e43a1b41805234e81c7a41dbe49cdf4ae3d650e8a0a2bbcda1d9259bcb2161b","patch_raw_hash":"1a65655914acea12ebf116238890772099aa6fbacbdbb6c1484e688ef95482d7","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT00530868/history/26?patchToVersion=27","to_snapshot_hash":null},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT00530868","nct_id":"NCT00530868"},"versions":{"from_version":26,"submitted_date":"2022-09-23","to_version":27}}