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
Hauptverfasser: 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
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container_issue 2
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container_title Breast cancer research and treatment
container_volume 98
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.
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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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source MEDLINE; Springer Nature - Complete Springer Journals
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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