A double-blind trial of tamoxifen plus prednisolone versus tamoxifen plus placebo in postmenopausal women with metastatic breast cancer: A collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic

J. N. Ingle, J. A. Mailliard, Charles Lawrence Loprinzi, J. E. Krook, Daniel J Schaid, H. E. Windschitl, D. M. Pfeifle, P. S. Etzell, J. G. Gerstner, H. J. Long, J. F. Foley, C. L. Loprinzi, R. J. Dalton

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Abstract

This trial was conducted to determine if the reported superiority of tamoxifen (TAM) plus prednisolone (PRDLN) over TAM alone in postmenopausal women with metastatic breast cancer could be corroborated. A total of 326 patients were randomized on a double-blind trial to TAM (10 mg twice daily) plus placebo or TAM plus PRDLN (5 mg twice daily). Six patients (2%) were disqualified. Considering 256 patients with measurable or evaluable disease, objective responses were seen in 48 (38%) of 126 TAM patients and 61 (47%) of 130 TAM plus PRDLN patients (chi-square, P = 0.15). Considering all 320 evaluated patients, median time to disease progression was 11 months for TAM and 10 months for TAM plus PRDLN (log rank, P = 0.81), and median survival time was 35 and 32 months, respectively (P = 0.40). Covariate analyses showed no significant association between treatment and outcome. Weight gain and edema were significantly greater with TAM plus PRDLN. The addition of PRDLN to TAM is not advocated for the management of postmenopausal women with metastatic breast cancer.

Original languageEnglish (US)
Pages (from-to)34-39
Number of pages6
JournalCancer
Volume68
Issue number1
StatePublished - 1991

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Tamoxifen
Prednisolone
Placebos
Breast Neoplasms
Neoplasms
Therapeutics
Weight Gain
Disease Progression
Edema
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A double-blind trial of tamoxifen plus prednisolone versus tamoxifen plus placebo in postmenopausal women with metastatic breast cancer : A collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic. / Ingle, J. N.; Mailliard, J. A.; Loprinzi, Charles Lawrence; Krook, J. E.; Schaid, Daniel J; Windschitl, H. E.; Pfeifle, D. M.; Etzell, P. S.; Gerstner, J. G.; Long, H. J.; Foley, J. F.; Loprinzi, C. L.; Dalton, R. J.

In: Cancer, Vol. 68, No. 1, 1991, p. 34-39.

Research output: Contribution to journalArticle

Ingle, JN, Mailliard, JA, Loprinzi, CL, Krook, JE, Schaid, DJ, Windschitl, HE, Pfeifle, DM, Etzell, PS, Gerstner, JG, Long, HJ, Foley, JF, Loprinzi, CL & Dalton, RJ 1991, 'A double-blind trial of tamoxifen plus prednisolone versus tamoxifen plus placebo in postmenopausal women with metastatic breast cancer: A collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic', Cancer, vol. 68, no. 1, pp. 34-39.
Ingle, J. N. ; Mailliard, J. A. ; Loprinzi, Charles Lawrence ; Krook, J. E. ; Schaid, Daniel J ; Windschitl, H. E. ; Pfeifle, D. M. ; Etzell, P. S. ; Gerstner, J. G. ; Long, H. J. ; Foley, J. F. ; Loprinzi, C. L. ; Dalton, R. J. / A double-blind trial of tamoxifen plus prednisolone versus tamoxifen plus placebo in postmenopausal women with metastatic breast cancer : A collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic. In: Cancer. 1991 ; Vol. 68, No. 1. pp. 34-39.
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abstract = "This trial was conducted to determine if the reported superiority of tamoxifen (TAM) plus prednisolone (PRDLN) over TAM alone in postmenopausal women with metastatic breast cancer could be corroborated. A total of 326 patients were randomized on a double-blind trial to TAM (10 mg twice daily) plus placebo or TAM plus PRDLN (5 mg twice daily). Six patients (2{\%}) were disqualified. Considering 256 patients with measurable or evaluable disease, objective responses were seen in 48 (38{\%}) of 126 TAM patients and 61 (47{\%}) of 130 TAM plus PRDLN patients (chi-square, P = 0.15). Considering all 320 evaluated patients, median time to disease progression was 11 months for TAM and 10 months for TAM plus PRDLN (log rank, P = 0.81), and median survival time was 35 and 32 months, respectively (P = 0.40). Covariate analyses showed no significant association between treatment and outcome. Weight gain and edema were significantly greater with TAM plus PRDLN. The addition of PRDLN to TAM is not advocated for the management of postmenopausal women with metastatic breast cancer.",
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AU - Loprinzi, C. L.

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