Randomized trial of tamoxifen alone or combined with fluoxymesterone as adjuvant therapy in postmenopausal women with resected estrogen receptor positive breast cancer. North Central Cancer Treatment Group Trial 89-30-52
This clinical trial evaluated the addition of fluoxymesterone (Flu) to tamoxifen (Tam) in women with resected early stage breast cancer and attempted to corroborate the findings of superiority for the combination over Tam alone seen in a previous randomized trial in metastatic disease. Postmenopausa...
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Veröffentlicht in: | Breast cancer research and treatment 2006-07, Vol.98 (2), p.217-222 |
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creator | INGLE, James N SUMAN, Vera J PEREZ, Edith A MAILLIARD, James A KUGLER, John W KROOK, James E MICHALAK, John C PISANSKY, Thomas M WOLD, Lester E DONOHUE, John H GOETZ, Matthew P |
description | This clinical trial evaluated the addition of fluoxymesterone (Flu) to tamoxifen (Tam) in women with resected early stage breast cancer and attempted to corroborate the findings of superiority for the combination over Tam alone seen in a previous randomized trial in metastatic disease.
Postmenopausal women with early stage breast cancer that was known to be estrogen receptor (ER) positive were randomized to treatment with Tam (20 mg per day orally for 5 years) alone or combined with Flu (10 mg orally twice per day for 1 year). The primary endpoint was relapse-free survival (RFS) defined as local-regional or distant recurrence including ductal carcinoma in situ of the ipsilateral, but not contralateral breast, and death from any cause.
There were 541 eligible patients entered between 1991 and 1995 and the treatment arms were balanced with respect to patient characteristics. The median follow up of patients still alive was 11.4 years. No significant difference was found between Tam plus Flu and Tam alone in terms of RFS or overall survival. The adjusted hazard ratio (Tam+Flu/Tam) for relapse or death without relapse was estimated to be 0.84 (95% CI: 0.64-1.10) and that for death was 0.89 (95% CI: 0.67-1.18). As expected there was more virilization in women who received Flu.
This clinical trial did not demonstrate superiority of Tam plus Flu over Tam alone as adjuvant therapy for postmenopausal women with resected early breast cancer known to be ER positive. |
doi_str_mv | 10.1007/s10549-005-9152-1 |
format | Article |
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Postmenopausal women with early stage breast cancer that was known to be estrogen receptor (ER) positive were randomized to treatment with Tam (20 mg per day orally for 5 years) alone or combined with Flu (10 mg orally twice per day for 1 year). The primary endpoint was relapse-free survival (RFS) defined as local-regional or distant recurrence including ductal carcinoma in situ of the ipsilateral, but not contralateral breast, and death from any cause.
There were 541 eligible patients entered between 1991 and 1995 and the treatment arms were balanced with respect to patient characteristics. The median follow up of patients still alive was 11.4 years. No significant difference was found between Tam plus Flu and Tam alone in terms of RFS or overall survival. The adjusted hazard ratio (Tam+Flu/Tam) for relapse or death without relapse was estimated to be 0.84 (95% CI: 0.64-1.10) and that for death was 0.89 (95% CI: 0.67-1.18). As expected there was more virilization in women who received Flu.
This clinical trial did not demonstrate superiority of Tam plus Flu over Tam alone as adjuvant therapy for postmenopausal women with resected early breast cancer known to be ER positive.</description><identifier>ISSN: 0167-6806</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-005-9152-1</identifier><identifier>PMID: 16538529</identifier><identifier>CODEN: BCTRD6</identifier><language>eng</language><publisher>Dordrecht: Springer</publisher><subject>Adult ; Aged ; Biological and medical sciences ; Breast cancer ; Breast Neoplasms - chemistry ; Breast Neoplasms - drug therapy ; Breast Neoplasms - mortality ; Cancer research ; Cancer therapies ; Chemotherapy ; Clinical outcomes ; Clinical trials ; Disease-Free Survival ; Estrogens ; Female ; Fluoxymesterone - administration & dosage ; Fluoxymesterone - adverse effects ; Gynecology. Andrology. Obstetrics ; Humans ; Mammary gland diseases ; Medical research ; Medical sciences ; Middle Aged ; Older people ; Postmenopause ; Receptors, Estrogen - analysis ; Tamoxifen - administration & dosage ; Tamoxifen - adverse effects ; Tamoxifen - therapeutic use ; Tumors</subject><ispartof>Breast cancer research and treatment, 2006-07, Vol.98 (2), p.217-222</ispartof><rights>2006 INIST-CNRS</rights><rights>Springer Science+Business Media, Inc. 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-fe9fb0437da61b7531f9dd51e712d21c0ca58b7c5e5b80b5450b1f3f493a949d3</citedby><cites>FETCH-LOGICAL-c356t-fe9fb0437da61b7531f9dd51e712d21c0ca58b7c5e5b80b5450b1f3f493a949d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17982086$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16538529$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>INGLE, James N</creatorcontrib><creatorcontrib>SUMAN, Vera J</creatorcontrib><creatorcontrib>PEREZ, Edith A</creatorcontrib><creatorcontrib>MAILLIARD, James A</creatorcontrib><creatorcontrib>KUGLER, John W</creatorcontrib><creatorcontrib>KROOK, James E</creatorcontrib><creatorcontrib>MICHALAK, John C</creatorcontrib><creatorcontrib>PISANSKY, Thomas M</creatorcontrib><creatorcontrib>WOLD, Lester E</creatorcontrib><creatorcontrib>DONOHUE, John H</creatorcontrib><creatorcontrib>GOETZ, Matthew P</creatorcontrib><title>Randomized trial of tamoxifen alone or combined with fluoxymesterone as adjuvant therapy in postmenopausal women with resected estrogen receptor positive breast cancer. North Central Cancer Treatment Group Trial 89-30-52</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><description>This clinical trial evaluated the addition of fluoxymesterone (Flu) to tamoxifen (Tam) in women with resected early stage breast cancer and attempted to corroborate the findings of superiority for the combination over Tam alone seen in a previous randomized trial in metastatic disease.
Postmenopausal women with early stage breast cancer that was known to be estrogen receptor (ER) positive were randomized to treatment with Tam (20 mg per day orally for 5 years) alone or combined with Flu (10 mg orally twice per day for 1 year). The primary endpoint was relapse-free survival (RFS) defined as local-regional or distant recurrence including ductal carcinoma in situ of the ipsilateral, but not contralateral breast, and death from any cause.
There were 541 eligible patients entered between 1991 and 1995 and the treatment arms were balanced with respect to patient characteristics. The median follow up of patients still alive was 11.4 years. No significant difference was found between Tam plus Flu and Tam alone in terms of RFS or overall survival. The adjusted hazard ratio (Tam+Flu/Tam) for relapse or death without relapse was estimated to be 0.84 (95% CI: 0.64-1.10) and that for death was 0.89 (95% CI: 0.67-1.18). As expected there was more virilization in women who received Flu.
This clinical trial did not demonstrate superiority of Tam plus Flu over Tam alone as adjuvant therapy for postmenopausal women with resected early breast cancer known to be ER positive.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - chemistry</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - mortality</subject><subject>Cancer research</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Disease-Free Survival</subject><subject>Estrogens</subject><subject>Female</subject><subject>Fluoxymesterone - administration & dosage</subject><subject>Fluoxymesterone - adverse effects</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Mammary gland diseases</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Older people</subject><subject>Postmenopause</subject><subject>Receptors, Estrogen - analysis</subject><subject>Tamoxifen - administration & dosage</subject><subject>Tamoxifen - adverse effects</subject><subject>Tamoxifen - therapeutic use</subject><subject>Tumors</subject><issn>0167-6806</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpFkV9rFDEUxYModlv9AL5IEHxMzZ_JZPIoS22FoiD1echkbmyWnWRMMm3Xz-qHMeMu9Cncy--cw81B6B2jl4xS9SkzKhtNKJVEM8kJe4E2TCpBFGfqJdpQ1irSdrQ9Q-c57yilWlH9Gp2xVopOcr1Bf3-YMMbJ_4ERl-TNHkeHi5nik3cQsNnHADgmbOM0-FChR1_usdsv8ekwQS6QVsBkbMbd8mBCweUekpkP2Ac8x1wmCHE2S67Oj7EOR4MEGWypdtUixV91ncDCXGpSFfniHwAPCUwu2JpgIV3ibzFV4RZCSdVr-3-L7yqzRhR8neIy13k9odNEUCL5G_TKmX2Gt6f3Av38cnW3vSG336-_bj_fEitkW4gD7QbaCDWalg1KCub0OEoGivGRM0utkd2grAQ5dHSQjaQDc8I1Whjd6FFcoA9H3znF30s9qd_FJYUa2XPGm6btuKoQO0I2xZwTuH5OfjLp0DPar3X2xzr7Wme_1tmzqnl_Ml6GCcZnxam_Cnw8ASZbs3epfovPz5zSHaddK_4BSR2tKg</recordid><startdate>20060701</startdate><enddate>20060701</enddate><creator>INGLE, James N</creator><creator>SUMAN, Vera J</creator><creator>PEREZ, Edith A</creator><creator>MAILLIARD, James A</creator><creator>KUGLER, John W</creator><creator>KROOK, James E</creator><creator>MICHALAK, John C</creator><creator>PISANSKY, Thomas M</creator><creator>WOLD, Lester E</creator><creator>DONOHUE, John H</creator><creator>GOETZ, Matthew P</creator><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</scope><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>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>20060701</creationdate><title>Randomized trial of tamoxifen alone or combined with fluoxymesterone as adjuvant therapy in postmenopausal women with resected estrogen receptor positive breast cancer. North Central Cancer Treatment Group Trial 89-30-52</title><author>INGLE, James N ; SUMAN, Vera J ; PEREZ, Edith A ; MAILLIARD, James A ; KUGLER, John W ; KROOK, James E ; MICHALAK, John C ; PISANSKY, Thomas M ; WOLD, Lester E ; DONOHUE, John H ; GOETZ, Matthew P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-fe9fb0437da61b7531f9dd51e712d21c0ca58b7c5e5b80b5450b1f3f493a949d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - chemistry</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - mortality</topic><topic>Cancer research</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Disease-Free Survival</topic><topic>Estrogens</topic><topic>Female</topic><topic>Fluoxymesterone - administration & dosage</topic><topic>Fluoxymesterone - adverse effects</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Mammary gland diseases</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Older people</topic><topic>Postmenopause</topic><topic>Receptors, Estrogen - analysis</topic><topic>Tamoxifen - administration & dosage</topic><topic>Tamoxifen - adverse effects</topic><topic>Tamoxifen - therapeutic use</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>INGLE, James N</creatorcontrib><creatorcontrib>SUMAN, Vera J</creatorcontrib><creatorcontrib>PEREZ, Edith A</creatorcontrib><creatorcontrib>MAILLIARD, James A</creatorcontrib><creatorcontrib>KUGLER, John W</creatorcontrib><creatorcontrib>KROOK, James E</creatorcontrib><creatorcontrib>MICHALAK, John C</creatorcontrib><creatorcontrib>PISANSKY, Thomas M</creatorcontrib><creatorcontrib>WOLD, Lester E</creatorcontrib><creatorcontrib>DONOHUE, John H</creatorcontrib><creatorcontrib>GOETZ, Matthew P</creatorcontrib><collection>Pascal-Francis</collection><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 China</collection><collection>ProQuest Central Basic</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>INGLE, James N</au><au>SUMAN, Vera J</au><au>PEREZ, Edith A</au><au>MAILLIARD, James A</au><au>KUGLER, John W</au><au>KROOK, James E</au><au>MICHALAK, John C</au><au>PISANSKY, Thomas M</au><au>WOLD, Lester E</au><au>DONOHUE, John H</au><au>GOETZ, Matthew P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized trial of tamoxifen alone or combined with fluoxymesterone as adjuvant therapy in postmenopausal women with resected estrogen receptor positive breast cancer. North Central Cancer Treatment Group Trial 89-30-52</atitle><jtitle>Breast cancer research and treatment</jtitle><addtitle>Breast Cancer Res Treat</addtitle><date>2006-07-01</date><risdate>2006</risdate><volume>98</volume><issue>2</issue><spage>217</spage><epage>222</epage><pages>217-222</pages><issn>0167-6806</issn><eissn>1573-7217</eissn><coden>BCTRD6</coden><abstract>This clinical trial evaluated the addition of fluoxymesterone (Flu) to tamoxifen (Tam) in women with resected early stage breast cancer and attempted to corroborate the findings of superiority for the combination over Tam alone seen in a previous randomized trial in metastatic disease.
Postmenopausal women with early stage breast cancer that was known to be estrogen receptor (ER) positive were randomized to treatment with Tam (20 mg per day orally for 5 years) alone or combined with Flu (10 mg orally twice per day for 1 year). The primary endpoint was relapse-free survival (RFS) defined as local-regional or distant recurrence including ductal carcinoma in situ of the ipsilateral, but not contralateral breast, and death from any cause.
There were 541 eligible patients entered between 1991 and 1995 and the treatment arms were balanced with respect to patient characteristics. The median follow up of patients still alive was 11.4 years. No significant difference was found between Tam plus Flu and Tam alone in terms of RFS or overall survival. The adjusted hazard ratio (Tam+Flu/Tam) for relapse or death without relapse was estimated to be 0.84 (95% CI: 0.64-1.10) and that for death was 0.89 (95% CI: 0.67-1.18). As expected there was more virilization in women who received Flu.
This clinical trial did not demonstrate superiority of Tam plus Flu over Tam alone as adjuvant therapy for postmenopausal women with resected early breast cancer known to be ER positive.</abstract><cop>Dordrecht</cop><pub>Springer</pub><pmid>16538529</pmid><doi>10.1007/s10549-005-9152-1</doi><tpages>6</tpages></addata></record> |
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subjects | Adult Aged Biological and medical sciences Breast cancer Breast Neoplasms - chemistry Breast Neoplasms - drug therapy Breast Neoplasms - mortality Cancer research Cancer therapies Chemotherapy Clinical outcomes Clinical trials Disease-Free Survival Estrogens Female Fluoxymesterone - administration & dosage Fluoxymesterone - adverse effects Gynecology. Andrology. Obstetrics Humans Mammary gland diseases Medical research Medical sciences Middle Aged Older people Postmenopause Receptors, Estrogen - analysis Tamoxifen - administration & dosage Tamoxifen - adverse effects Tamoxifen - therapeutic use Tumors |
title | Randomized trial of tamoxifen alone or combined with fluoxymesterone as adjuvant therapy in postmenopausal women with resected estrogen receptor positive breast cancer. North Central Cancer Treatment Group Trial 89-30-52 |
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