{"id":"https://openalex.org/W2594401637","doi":"https://doi.org/10.1158/1538-7445.sabcs16-p2-11-02","title":"Abstract P2-11-02: A longitudinal look at toxicity management within a platform trial: Lessons from the I-SPY 2 TRIAL","display_name":"Abstract P2-11-02: A longitudinal look at toxicity management within a platform trial: Lessons from the I-SPY 2 TRIAL","publication_year":2017,"publication_date":"2017-02-15","ids":{"openalex":"https://openalex.org/W2594401637","doi":"https://doi.org/10.1158/1538-7445.sabcs16-p2-11-02","mag":"2594401637"},"language":"en","primary_location":{"id":"doi:10.1158/1538-7445.sabcs16-p2-11-02","doi":"https://doi.org/10.1158/1538-7445.sabcs16-p2-11-02","is_oa":false,"landing_page_url":"https://doi.org/10.1158/1538-7445.sabcs16-p2-11-02","pdf_url":null,"source":{"id":"https://openalex.org/S168522863","display_name":"Cancer Research","issn_l":"0008-5472","issn":["0008-5472","1538-7445"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320273","host_organization_name":"American Association for Cancer Research","host_organization_lineage":["https://openalex.org/P4310320273"],"host_organization_lineage_names":["American Association for Cancer Research"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cancer Research","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":null,"display_name":"M Paoloni","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4405267949","display_name":"Berry Consultants, LLC (United States)","ror":"https://ror.org/054btrt70","country_code":"US","type":"company","lineage":["https://openalex.org/I4405267949"]},{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"M Paoloni","raw_affiliation_strings":["QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","Berry Consultants, Austin, TX","University of California, San Francisco, San Francisco, CA","University of Minnesota, Minneapolis, MN","University of Pennsylvania, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516","https://openalex.org/I180670191","https://openalex.org/I4405267949","https://openalex.org/I79576946"]},{"raw_affiliation_string":"Berry Consultants, Austin, TX","institution_ids":["https://openalex.org/I4405267949"]},{"raw_affiliation_string":"University of California, San Francisco, San Francisco, CA","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"University of Pennsylvania, Philadelphia, PA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5050253207","display_name":"Julia Lyandres","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4405267949","display_name":"Berry Consultants, LLC (United States)","ror":"https://ror.org/054btrt70","country_code":"US","type":"company","lineage":["https://openalex.org/I4405267949"]},{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"J Lyandres","raw_affiliation_strings":["QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","Berry Consultants, Austin, TX","University of California, San Francisco, San Francisco, CA","University of Minnesota, Minneapolis, MN","University of Pennsylvania, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516","https://openalex.org/I180670191","https://openalex.org/I4405267949","https://openalex.org/I79576946"]},{"raw_affiliation_string":"Berry Consultants, Austin, TX","institution_ids":["https://openalex.org/I4405267949"]},{"raw_affiliation_string":"University of California, San Francisco, San Francisco, CA","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"University of Pennsylvania, Philadelphia, PA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5086477078","display_name":"MB Buxton","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4405267949","display_name":"Berry Consultants, LLC (United States)","ror":"https://ror.org/054btrt70","country_code":"US","type":"company","lineage":["https://openalex.org/I4405267949"]},{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"MB Buxton","raw_affiliation_strings":["QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","Berry Consultants, Austin, TX","University of California, San Francisco, San Francisco, CA","University of Minnesota, Minneapolis, MN","University of Pennsylvania, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516","https://openalex.org/I180670191","https://openalex.org/I4405267949","https://openalex.org/I79576946"]},{"raw_affiliation_string":"Berry Consultants, Austin, TX","institution_ids":["https://openalex.org/I4405267949"]},{"raw_affiliation_string":"University of California, San Francisco, San Francisco, CA","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"University of Pennsylvania, Philadelphia, PA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5073571977","display_name":"Donald A. Berry","orcid":"https://orcid.org/0000-0002-7657-3871","observed_orcids":["https://orcid.org/0000-0002-7657-3871"]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4405267949","display_name":"Berry Consultants, LLC (United States)","ror":"https://ror.org/054btrt70","country_code":"US","type":"company","lineage":["https://openalex.org/I4405267949"]},{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"DA Berry","raw_affiliation_strings":["QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","Berry Consultants, Austin, TX","University of California, San Francisco, San Francisco, CA","University of Minnesota, Minneapolis, MN","University of Pennsylvania, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516","https://openalex.org/I180670191","https://openalex.org/I4405267949","https://openalex.org/I79576946"]},{"raw_affiliation_string":"Berry Consultants, Austin, TX","institution_ids":["https://openalex.org/I4405267949"]},{"raw_affiliation_string":"University of California, San Francisco, San Francisco, CA","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"University of Pennsylvania, Philadelphia, PA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072789687","display_name":"Laura J. Esserman","orcid":"https://orcid.org/0000-0001-9202-4568","observed_orcids":["https://orcid.org/0000-0001-9202-4568"]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4405267949","display_name":"Berry Consultants, LLC (United States)","ror":"https://ror.org/054btrt70","country_code":"US","type":"company","lineage":["https://openalex.org/I4405267949"]},{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"LJ Esserman","raw_affiliation_strings":["QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","Berry Consultants, Austin, TX","University of California, San Francisco, San Francisco, CA","University of Minnesota, Minneapolis, MN","University of Pennsylvania, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516","https://openalex.org/I180670191","https://openalex.org/I4405267949","https://openalex.org/I79576946"]},{"raw_affiliation_string":"Berry Consultants, Austin, TX","institution_ids":["https://openalex.org/I4405267949"]},{"raw_affiliation_string":"University of California, San Francisco, San Francisco, CA","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"University of Pennsylvania, Philadelphia, PA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005537242","display_name":"Angela M. DeMichele","orcid":"https://orcid.org/0000-0003-1297-4251","observed_orcids":["https://orcid.org/0000-0003-1297-4251"]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4405267949","display_name":"Berry Consultants, LLC (United States)","ror":"https://ror.org/054btrt70","country_code":"US","type":"company","lineage":["https://openalex.org/I4405267949"]},{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"A DeMichele","raw_affiliation_strings":["QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","Berry Consultants, Austin, TX","University of California, San Francisco, San Francisco, CA","University of Minnesota, Minneapolis, MN","University of Pennsylvania, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516","https://openalex.org/I180670191","https://openalex.org/I4405267949","https://openalex.org/I79576946"]},{"raw_affiliation_string":"Berry Consultants, Austin, TX","institution_ids":["https://openalex.org/I4405267949"]},{"raw_affiliation_string":"University of California, San Francisco, San Francisco, CA","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"University of Pennsylvania, Philadelphia, PA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5033966004","display_name":"Douglas Yee","orcid":"https://orcid.org/0000-0002-3387-4009","observed_orcids":["https://orcid.org/0000-0002-3387-4009"]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4405267949","display_name":"Berry Consultants, LLC (United States)","ror":"https://ror.org/054btrt70","country_code":"US","type":"company","lineage":["https://openalex.org/I4405267949"]},{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"D Yee","raw_affiliation_strings":["QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","Berry Consultants, Austin, TX","University of California, San Francisco, San Francisco, CA","University of Minnesota, Minneapolis, MN","University of Pennsylvania, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"QuantumLeap Healthcare Collaborative, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Berry Consultants, Austin, TX; University of Pennsylvania, Philadelphia, PA; University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516","https://openalex.org/I180670191","https://openalex.org/I4405267949","https://openalex.org/I79576946"]},{"raw_affiliation_string":"Berry Consultants, Austin, TX","institution_ids":["https://openalex.org/I4405267949"]},{"raw_affiliation_string":"University of California, San Francisco, San Francisco, CA","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"University of Minnesota, Minneapolis, MN","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"University of Pennsylvania, Philadelphia, PA","institution_ids":["https://openalex.org/I79576946"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"77","issue":"4_Supplement","first_page":"P2","last_page":"11"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.8925999999046326,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.8925999999046326,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T10183","display_name":"Breast Cancer Treatment Studies","score":0.08500000089406967,"subfield":{"id":"https://openalex.org/subfields/1306","display_name":"Cancer Research"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.008100000210106373,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/platform-trials","display_name":"platform trials","score":0.7590000033378601},{"id":"https://openalex.org/keywords/i-spy2-trial","display_name":"I-SPY2 trial","score":0.9459999799728394},{"id":"https://openalex.org/keywords/toxicity-management","display_name":"toxicity management","score":0.8389999866485596},{"id":"https://openalex.org/keywords/safety-monitoring","display_name":"safety monitoring","score":0.8569999933242798},{"id":"https://openalex.org/keywords/neoadjuvant-therapy","display_name":"neoadjuvant therapy","score":0.7919999957084656},{"id":"https://openalex.org/keywords/high-risk-breast-cancer","display_name":"high-risk breast cancer","score":0.8450000286102295},{"id":"https://openalex.org/keywords/response-adaptive-randomization","display_name":"response-adaptive randomization","score":0.8790000081062317},{"id":"https://openalex.org/keywords/risk-based-monitoring","display_name":"risk-based monitoring","score":0.7269999980926514},{"id":"https://openalex.org/keywords/adverse-event-reporting","display_name":"adverse event reporting","score":0.5189999938011169},{"id":"https://openalex.org/keywords/investigational-agents","display_name":"investigational agents","score":0.609000027179718},{"id":"https://openalex.org/keywords/paclitaxel","display_name":"paclitaxel","score":0.7120000123977661},{"id":"https://openalex.org/keywords/doxorubicin-and-cyclophosphamide","display_name":"doxorubicin-cyclophosphamide","score":0.890999972820282},{"id":"https://openalex.org/keywords/pathological-complete-response","display_name":"pathological complete response","score":0.675000011920929},{"id":"https://openalex.org/keywords/data-and-safety-monitoring-board","display_name":"data safety monitoring board","score":0.6370000243186951},{"id":"https://openalex.org/keywords/eligibility-criteria","display_name":"eligibility criteria","score":0.32499998807907104},{"id":"https://openalex.org/keywords/immunotherapy","display_name":"immunotherapy","score":0.3529999852180481}],"concepts":[{"id":"https://openalex.org/C2781413609","wikidata":"https://www.wikidata.org/wiki/Q7308373","display_name":"Regimen","level":2,"score":0.7310448884963989},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6651873588562012},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5624945163726807},{"id":"https://openalex.org/C73751289","wikidata":"https://www.wikidata.org/wiki/Q2985397","display_name":"Data monitoring committee","level":3,"score":0.5295729637145996},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5214090347290039},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.5195120573043823},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.4988071918487549},{"id":"https://openalex.org/C31760486","wikidata":"https://www.wikidata.org/wiki/Q7180990","display_name":"Phases of clinical research","level":3,"score":0.47562745213508606},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.4652121365070343},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.4255443811416626},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1158/1538-7445.sabcs16-p2-11-02","doi":"https://doi.org/10.1158/1538-7445.sabcs16-p2-11-02","is_oa":false,"landing_page_url":"https://doi.org/10.1158/1538-7445.sabcs16-p2-11-02","pdf_url":null,"source":{"id":"https://openalex.org/S168522863","display_name":"Cancer Research","issn_l":"0008-5472","issn":["0008-5472","1538-7445"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320273","host_organization_name":"American Association for Cancer Research","host_organization_lineage":["https://openalex.org/P4310320273"],"host_organization_lineage_names":["American Association for Cancer Research"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cancer Research","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9391000270843506,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2512757895","https://openalex.org/W2005494948","https://openalex.org/W2989861603","https://openalex.org/W2600548649","https://openalex.org/W4404969738","https://openalex.org/W2339056607","https://openalex.org/W3135763817","https://openalex.org/W2088179944","https://openalex.org/W4246927264","https://openalex.org/W2954577563"],"abstract_inverted_index":{"Abstract":[0],"Background:":[1],"I-SPY":[2,109,127,199,422,497],"2":[3,8,110,200,498],"is":[4,62,73,134],"a":[5,18,69,89,101,130,189,268,352,431,459,491],"multicenter,":[6],"phase":[7],"trial":[9,156,194,387,397,406],"using":[10],"response-adaptive":[11],"randomization":[12],"within":[13,218,379,464,490],"biomarker":[14],"subtypes":[15],"to":[16,27,74,112,123,162,233,241,289,385,433],"evaluate":[17,75],"series":[19],"of":[20,79,85,97,183,216,222,270,272,303,334,372,396,450,503],"investigational":[21,40,81,132,164,185,220,229,250,299,311,418],"agents":[22,419],"or":[23,143],"regimens":[24,455],"when":[25,318,367],"added":[26],"standard":[28],"neoadjuvant":[29,381],"therapy":[30],"for":[31,136,157,227,309,351,461],"women":[32,125,261],"with":[33,297,439],"high-risk":[34],"stage":[35],"II/III":[36],"breast":[37],"cancer":[38],"-":[39],"agent":[41,139],"(I)":[42],"+paclitaxel":[43],"(T)":[44],"qwk,":[45],"doxorubicin":[46],"&":[47],"cyclophosphamide":[48],"(AC)":[49],"q2-3":[50],"wk":[51],"x":[52],"4":[53],"vs.":[54],"T+/-HP/AC":[55],"(control":[56],"arm(s)).":[57],"Although":[58],"the":[59,76,95,106,113,137,155,184,193,214,223,290,330,335,370,386,394,447,496,504],"primary":[60],"endpoint":[61],"pathologic":[63],"complete":[64],"response":[65],"(pCR)":[66],"at":[67,487],"surgery,":[68],"key":[70],"secondary":[71],"aim":[72],"toxicity":[77,488],"profiles":[78,226],"these":[80],"agents.":[82],"Distinct":[83],"aspects":[84],"safety":[86,98,204,348,377,395,462],"monitoring":[87,322],"in":[88,100,126,154,177],"platform":[90,405,466,492],"trial,":[91,138],"as":[92,94,149,278,284,286,416,458],"well":[93,285,401],"specificities":[96],"management":[99,215,463,489],"potentially":[102],"curative":[103],"population":[104],"make":[105],"experiences":[107],"from":[108,495],"valuable":[111],"community.":[114],"Methods:":[115],"Inclusion":[116],"and":[117,160,165,169,175,206,259,282,313,332,345,355,364,393,410,425,454,456],"exclusion":[118],"criteria":[119,152,293],"are":[120,147,173,231,239,420],"uniformly":[121,317],"applied":[122],"all":[124,163],"2.":[128],"When":[129],"new":[131,298,417,452],"agent/regimen":[133,186,191,221,230],"planned":[135],"specific":[140,190,314,347],"laboratory/hematologic":[141],"limits":[142],"additional":[144,451],"required":[145],"tests":[146],"added,":[148],"needed.":[150],"Eligibility":[151],"remain":[153],"its":[158],"duration":[159],"apply":[161],"control":[166],"arms.":[167,300],"Laboratory":[168],"adverse":[170,343],"event":[171],"data":[172,339],"collected":[174],"monitored":[176,308],"real":[178],"time.":[179],"The":[180],"lead":[181],"investigator":[182],"who":[187],"chaperones":[188],"through":[192],"(\u201cAgent":[195],"Chaperone\u201d),":[196],"Medical":[197],"Monitor,":[198],"Agents":[201],"Committee,":[202],"CRO":[203],"group,":[205],"an":[207,228,408],"active":[208],"DSMB":[209],"that":[210,327,414],"meets":[211],"monthly":[212],"oversee":[213],"toxicities":[217,315],"each":[219,310],"trial.":[224],"Toxicity":[225],"compared":[232],"their":[234],"relevant":[235],"control.":[236],"Safety":[237,358],"analyses":[238],"intention":[240],"treat.":[242],"Results:":[243],"From":[244],"March":[245],"2010-May":[246],"2016,":[247],"eleven":[248],"(11)":[249],"agents/regimens":[251,266],"have":[252,256,262,294,306,360],"opened":[253],"(and":[254],"6":[255],"completed":[257],"evaluation)":[258],"973":[260],"been":[263,295,307,325,361,400],"randomized.":[264],"These":[265,443],"span":[267],"variety":[269],"mechanisms":[271],"action":[273],"including":[274,341],"targeted":[275],"therapies":[276],"such":[277],"small":[279],"molecule":[280],"inhibitors":[281],"antibodies,":[283],"immunotherapies.":[287],"Additions":[288],"trial's":[291,336],"eligibility":[292],"made":[296],"Adverse":[301],"events":[302,344],"special":[304],"interest":[305],"arm":[312],"treated":[316],"applicable.":[319],"A":[320,404,484],"risk-based":[321],"plan":[323],"has":[324,388,399,429],"implemented":[326],"focuses":[328],"on":[329],"collection":[331],"review":[333],"most":[337],"critical":[338],"elements":[340],"serious":[342],"drug":[346],"issues,":[349],"allowing":[350],"more":[353],"efficient":[354],"focused":[356,411],"effort.":[357],"issues":[359],"quickly":[362],"addressed":[363],"requirements":[365],"updated,":[366],"needed,":[368],"given":[369],"importance":[371],"limiting":[373],"(or":[374],"avoiding)":[375],"long-term":[376],"complications":[378],"this":[380],"patient":[382],"population.":[383],"Accrual":[384],"(been)":[389],"maintained":[390],"over":[391],"time":[392],"participants":[398],"managed.":[402],"Conclusion:":[403],"requires":[407],"evolving,":[409],"safety-monitoring":[412],"process":[413],"adapts":[415],"included.":[421],"2's":[423],"infrastructure":[424],"team":[426],"science":[427],"approach":[428],"created":[430],"system":[432],"manage":[434],"patients":[435],"across":[436],"multiple":[437],"arms":[438],"different":[440],"risk":[441],"profiles.":[442],"practices":[444],"will":[445],"support":[446],"safe":[448],"evaluation":[449],"combinations":[453],"serves":[457],"guide":[460],"standing":[465],"trials.":[467],"Citation":[468],"Format:":[469],"Paoloni":[470],"M,":[471],"Lyandres":[472],"J,":[473],"Buxton":[474],"MB,":[475],"Berry":[476],"DA,":[477],"Esserman":[478],"LJ,":[479],"DeMichele":[480],"A,":[481],"Yee":[482],"D.":[483],"longitudinal":[485],"look":[486],"trial:":[493],"Lessons":[494],"TRIAL":[499],"[abstract].":[500],"In:":[501],"Proceedings":[502],"2016":[505,511],"San":[506,514],"Antonio":[507],"Breast":[508],"Cancer":[509,520],"Symposium;":[510],"Dec":[512],"6-10;":[513],"Antonio,":[515],"TX.":[516],"Philadelphia":[517],"(PA):":[518],"AACR;":[519],"Res":[521],"2017;77(4":[522],"Suppl):Abstract":[523],"nr":[524],"P2-11-02.":[525]},"counts_by_year":[{"year":2019,"cited_by_count":2}],"updated_date":"2026-10-14T16:39:01.820549","created_date":"2017-03-16T00:00:00"}
