Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials
Purpose Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of part...
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| Veröffentlicht in: | Breast cancer research and treatment 2018-02, Vol.168 (1), p.35-41 |
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| creator | Lynce, Filipa Blackburn, Matthew J. Cai, Ling Wang, Heping Rubinstein, Larry Harris, Pamela Isaacs, Claudine Pohlmann, Paula R. |
| description | Purpose
Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials.
Methods
We performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths.
Results
De-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (
p
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| doi_str_mv | 10.1007/s10549-017-4563-3 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5940334</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A528526183</galeid><sourcerecordid>A528526183</sourcerecordid><originalsourceid>FETCH-LOGICAL-c568t-cf7ecce591b765413fb366e8d1c3759973e2fae4ac47683f7f686774afcb78e43</originalsourceid><addsrcrecordid>eNp1ksFu1DAQhiMEokvhAbggS0gVlxQ7duzkglStCqxUAYdytrzeycaVYwfbqdT34UFxSLt0EciHkWa--a2Z-YviNcHnBGPxPhJcs7bERJSs5rSkT4oVqQUtRUXE02KFCRclbzA_KV7EeIMxbgVunxcnVUtIS2u2Kn6uexWUThBMTEZHpNwO-SlpP0BEvkPbACompJXTENCokgGXIgIXvLWwQ8ah1AP6kgveKYvWC7hxWS5NCR4S1z0ENd6hy1tlp98w-hb8PqgBxdG76EMWG3sVAW2QtsYZndVSMMrGl8WzLgd4dR9Pi-8fL6_Xn8urr58264urUte8SaXuBGgNdUu2gteM0G5LOYdmRzQVddsKClWngCnNBG9oJzrecCGY6vRWNMDoafFh0R2n7QA7nScNysoxmEGFO-mVkccVZ3q597eybhmmdBZ4dy8Q_I8JYpKDiRqsVQ78FCVpecWqTDcZffsXeuOnkDcYZZVvixnGeYIDtVcWpHGdz__qWVRe1FVTV5w0NFPn_6Dy28FgtHfQmZw_ajh71NCDsqmP3k7zWeIxSBZQBx9jgO6wDILl7EG5eFBmD8rZg3LuefN4i4eOB9NloFqAmEtuD-HP6P9X_QXpNOkT</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2007040041</pqid></control><display><type>article</type><title>Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Lynce, Filipa ; Blackburn, Matthew J. ; Cai, Ling ; Wang, Heping ; Rubinstein, Larry ; Harris, Pamela ; Isaacs, Claudine ; Pohlmann, Paula R.</creator><creatorcontrib>Lynce, Filipa ; Blackburn, Matthew J. ; Cai, Ling ; Wang, Heping ; Rubinstein, Larry ; Harris, Pamela ; Isaacs, Claudine ; Pohlmann, Paula R.</creatorcontrib><description>Purpose
Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials.
Methods
We performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths.
Results
De-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (
p
< 0.001). Breast cancer patients had more clinical responses than non-BC patients (18.3% vs. 4.3%, respectively). Along with the higher rate of response, BC patients remained on phase I trials longer than non-BC patients with a median of 70 days while the latter were on trial for a median of 57 days. The overall rate of death related to the treatment drugs was 0.47%.
Conclusions
Our data confirm our hypothesis that when compared to a general population of patients with cancer enrolled on phase I clinical trials, BC patients tend to derive clinical benefit from these therapies with similar toxicity profile. This evidence further supports enrollment of BC patients on phase I trials.</description><identifier>ISSN: 0167-6806</identifier><identifier>ISSN: 1573-7217</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-017-4563-3</identifier><identifier>PMID: 29119354</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic agents ; Antineoplastic Agents - adverse effects ; Breast cancer ; Breast Neoplasms - drug therapy ; Cancer diagnosis ; Cancer patients ; Cancer research ; Cancer therapies ; Cancer treatment ; Clinical Trial ; Clinical trials ; Clinical Trials, Phase I as Topic - economics ; Clinical Trials, Phase I as Topic - statistics & numerical data ; Diagnosis ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Drug-Related Side Effects and Adverse Reactions - etiology ; Enrollments ; Female ; Humans ; Medical schools ; Medicine ; Medicine & Public Health ; Middle Aged ; National Cancer Institute (U.S.) - economics ; Oncology ; Patient outcomes ; Patient Selection ; Product development ; Response Evaluation Criteria in Solid Tumors ; Retrospective Studies ; Time Factors ; Toxicity ; United States ; Young Adult</subject><ispartof>Breast cancer research and treatment, 2018-02, Vol.168 (1), p.35-41</ispartof><rights>Springer Science+Business Media, LLC 2017</rights><rights>COPYRIGHT 2018 Springer</rights><rights>Breast Cancer Research and Treatment is a copyright of Springer, (2017). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c568t-cf7ecce591b765413fb366e8d1c3759973e2fae4ac47683f7f686774afcb78e43</citedby><cites>FETCH-LOGICAL-c568t-cf7ecce591b765413fb366e8d1c3759973e2fae4ac47683f7f686774afcb78e43</cites><orcidid>0000-0001-6615-7076</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10549-017-4563-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-017-4563-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27922,27923,41486,42555,51317</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29119354$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lynce, Filipa</creatorcontrib><creatorcontrib>Blackburn, Matthew J.</creatorcontrib><creatorcontrib>Cai, Ling</creatorcontrib><creatorcontrib>Wang, Heping</creatorcontrib><creatorcontrib>Rubinstein, Larry</creatorcontrib><creatorcontrib>Harris, Pamela</creatorcontrib><creatorcontrib>Isaacs, Claudine</creatorcontrib><creatorcontrib>Pohlmann, Paula R.</creatorcontrib><title>Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>Purpose
Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials.
Methods
We performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths.
Results
De-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (
p
< 0.001). Breast cancer patients had more clinical responses than non-BC patients (18.3% vs. 4.3%, respectively). Along with the higher rate of response, BC patients remained on phase I trials longer than non-BC patients with a median of 70 days while the latter were on trial for a median of 57 days. The overall rate of death related to the treatment drugs was 0.47%.
Conclusions
Our data confirm our hypothesis that when compared to a general population of patients with cancer enrolled on phase I clinical trials, BC patients tend to derive clinical benefit from these therapies with similar toxicity profile. This evidence further supports enrollment of BC patients on phase I trials.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Cancer diagnosis</subject><subject>Cancer patients</subject><subject>Cancer research</subject><subject>Cancer therapies</subject><subject>Cancer treatment</subject><subject>Clinical Trial</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase I as Topic - economics</subject><subject>Clinical Trials, Phase I as Topic - statistics & numerical data</subject><subject>Diagnosis</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>Enrollments</subject><subject>Female</subject><subject>Humans</subject><subject>Medical schools</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>National Cancer Institute (U.S.) - economics</subject><subject>Oncology</subject><subject>Patient outcomes</subject><subject>Patient Selection</subject><subject>Product development</subject><subject>Response Evaluation Criteria in Solid Tumors</subject><subject>Retrospective Studies</subject><subject>Time Factors</subject><subject>Toxicity</subject><subject>United States</subject><subject>Young Adult</subject><issn>0167-6806</issn><issn>1573-7217</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1ksFu1DAQhiMEokvhAbggS0gVlxQ7duzkglStCqxUAYdytrzeycaVYwfbqdT34UFxSLt0EciHkWa--a2Z-YviNcHnBGPxPhJcs7bERJSs5rSkT4oVqQUtRUXE02KFCRclbzA_KV7EeIMxbgVunxcnVUtIS2u2Kn6uexWUThBMTEZHpNwO-SlpP0BEvkPbACompJXTENCokgGXIgIXvLWwQ8ah1AP6kgveKYvWC7hxWS5NCR4S1z0ENd6hy1tlp98w-hb8PqgBxdG76EMWG3sVAW2QtsYZndVSMMrGl8WzLgd4dR9Pi-8fL6_Xn8urr58264urUte8SaXuBGgNdUu2gteM0G5LOYdmRzQVddsKClWngCnNBG9oJzrecCGY6vRWNMDoafFh0R2n7QA7nScNysoxmEGFO-mVkccVZ3q597eybhmmdBZ4dy8Q_I8JYpKDiRqsVQ78FCVpecWqTDcZffsXeuOnkDcYZZVvixnGeYIDtVcWpHGdz__qWVRe1FVTV5w0NFPn_6Dy28FgtHfQmZw_ajh71NCDsqmP3k7zWeIxSBZQBx9jgO6wDILl7EG5eFBmD8rZg3LuefN4i4eOB9NloFqAmEtuD-HP6P9X_QXpNOkT</recordid><startdate>20180201</startdate><enddate>20180201</enddate><creator>Lynce, Filipa</creator><creator>Blackburn, Matthew J.</creator><creator>Cai, Ling</creator><creator>Wang, Heping</creator><creator>Rubinstein, Larry</creator><creator>Harris, Pamela</creator><creator>Isaacs, Claudine</creator><creator>Pohlmann, Paula R.</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6615-7076</orcidid></search><sort><creationdate>20180201</creationdate><title>Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials</title><author>Lynce, Filipa ; Blackburn, Matthew J. ; Cai, Ling ; Wang, Heping ; Rubinstein, Larry ; Harris, Pamela ; Isaacs, Claudine ; Pohlmann, Paula R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c568t-cf7ecce591b765413fb366e8d1c3759973e2fae4ac47683f7f686774afcb78e43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Cancer diagnosis</topic><topic>Cancer patients</topic><topic>Cancer research</topic><topic>Cancer therapies</topic><topic>Cancer treatment</topic><topic>Clinical Trial</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase I as Topic - economics</topic><topic>Clinical Trials, Phase I as Topic - statistics & numerical data</topic><topic>Diagnosis</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>Enrollments</topic><topic>Female</topic><topic>Humans</topic><topic>Medical schools</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>National Cancer Institute (U.S.) - economics</topic><topic>Oncology</topic><topic>Patient outcomes</topic><topic>Patient Selection</topic><topic>Product development</topic><topic>Response Evaluation Criteria in Solid Tumors</topic><topic>Retrospective Studies</topic><topic>Time Factors</topic><topic>Toxicity</topic><topic>United States</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lynce, Filipa</creatorcontrib><creatorcontrib>Blackburn, Matthew J.</creatorcontrib><creatorcontrib>Cai, Ling</creatorcontrib><creatorcontrib>Wang, Heping</creatorcontrib><creatorcontrib>Rubinstein, Larry</creatorcontrib><creatorcontrib>Harris, Pamela</creatorcontrib><creatorcontrib>Isaacs, Claudine</creatorcontrib><creatorcontrib>Pohlmann, Paula R.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lynce, Filipa</au><au>Blackburn, Matthew J.</au><au>Cai, Ling</au><au>Wang, Heping</au><au>Rubinstein, Larry</au><au>Harris, Pamela</au><au>Isaacs, Claudine</au><au>Pohlmann, Paula R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials</atitle><jtitle>Breast cancer research and treatment</jtitle><stitle>Breast Cancer Res Treat</stitle><addtitle>Breast Cancer Res Treat</addtitle><date>2018-02-01</date><risdate>2018</risdate><volume>168</volume><issue>1</issue><spage>35</spage><epage>41</epage><pages>35-41</pages><issn>0167-6806</issn><issn>1573-7217</issn><eissn>1573-7217</eissn><abstract>Purpose
Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials.
Methods
We performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths.
Results
De-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (
p
< 0.001). Breast cancer patients had more clinical responses than non-BC patients (18.3% vs. 4.3%, respectively). Along with the higher rate of response, BC patients remained on phase I trials longer than non-BC patients with a median of 70 days while the latter were on trial for a median of 57 days. The overall rate of death related to the treatment drugs was 0.47%.
Conclusions
Our data confirm our hypothesis that when compared to a general population of patients with cancer enrolled on phase I clinical trials, BC patients tend to derive clinical benefit from these therapies with similar toxicity profile. This evidence further supports enrollment of BC patients on phase I trials.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>29119354</pmid><doi>10.1007/s10549-017-4563-3</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-6615-7076</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0167-6806 |
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| subjects | Adult Aged Aged, 80 and over Antineoplastic agents Antineoplastic Agents - adverse effects Breast cancer Breast Neoplasms - drug therapy Cancer diagnosis Cancer patients Cancer research Cancer therapies Cancer treatment Clinical Trial Clinical trials Clinical Trials, Phase I as Topic - economics Clinical Trials, Phase I as Topic - statistics & numerical data Diagnosis Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - etiology Enrollments Female Humans Medical schools Medicine Medicine & Public Health Middle Aged National Cancer Institute (U.S.) - economics Oncology Patient outcomes Patient Selection Product development Response Evaluation Criteria in Solid Tumors Retrospective Studies Time Factors Toxicity United States Young Adult |
| title | Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials |
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