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

James N. Ingle, Vera Jean Suman, James A. Mailliard, John W. Kugler, James E. Krook, John C. Michalak, Thomas M. Pisansky, Lester E. Wold, John H. Donohue, Matthew Philip Goetz, Edith A. Perez

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

Purpose. 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. Patients and methods. 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. Results. 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. Conclusions. 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.

Original languageEnglish (US)
Pages (from-to)217-222
Number of pages6
JournalBreast Cancer Research and Treatment
Volume98
Issue number2
DOIs
StatePublished - Jul 2006

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Fluoxymesterone
Tamoxifen
Estrogen Receptors
Breast Neoplasms
Neoplasms
Recurrence
Therapeutics
Survival
Clinical Trials
Virilism
Carcinoma, Intraductal, Noninfiltrating
Cause of Death
Breast
Arm

Keywords

  • Adjuvant therapy
  • Combination hormonal therapy
  • Early breast cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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. / Ingle, James N.; Suman, Vera Jean; Mailliard, James A.; Kugler, John W.; Krook, James E.; Michalak, John C.; Pisansky, Thomas M.; Wold, Lester E.; Donohue, John H.; Goetz, Matthew Philip; Perez, Edith A.

In: Breast Cancer Research and Treatment, Vol. 98, No. 2, 07.2006, p. 217-222.

Research output: Contribution to journalArticle

Ingle, James N. ; Suman, Vera Jean ; Mailliard, James A. ; Kugler, John W. ; Krook, James E. ; Michalak, John C. ; Pisansky, Thomas M. ; Wold, Lester E. ; Donohue, John H. ; Goetz, Matthew Philip ; Perez, Edith A. / 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. In: Breast Cancer Research and Treatment. 2006 ; Vol. 98, No. 2. pp. 217-222.
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abstract = "Purpose. 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. Patients and methods. 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. Results. 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. Conclusions. 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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T1 - 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

AU - Ingle, James N.

AU - Suman, Vera Jean

AU - Mailliard, James A.

AU - Kugler, John W.

AU - Krook, James E.

AU - Michalak, John C.

AU - Pisansky, Thomas M.

AU - Wold, Lester E.

AU - Donohue, John H.

AU - Goetz, Matthew Philip

AU - Perez, Edith A.

PY - 2006/7

Y1 - 2006/7

N2 - Purpose. 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. Patients and methods. 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. Results. 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. Conclusions. 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.

AB - Purpose. 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. Patients and methods. 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. Results. 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. Conclusions. 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.

KW - Adjuvant therapy

KW - Combination hormonal therapy

KW - Early breast cancer

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