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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

Breast Cancer Research and Treatment volume 98, pages 217–222 (2006)Cite this article

Summary

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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Acknowledgements

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-15083, CA-35113, CA-35269, CA-63849, CA-35103, CA-35195, CA-35272, CA-35101, CA-37417, CA-35415, CA-52352, CA-35448, CA-60276. Additional participating institutions include: Meritcare Hospital CCOP, Fargo, ND 58122 (Ralph Levitt, M.D.); Toledo Community Hospital Oncology Program CCOP, Toledo, OH 43610 (Paul L. Schaefer, M.D.); Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA 52403 (Martin Wiesenfeld, M.D.); Quain and Ramstad Clinic, Bismarck, ND 58506 (Edward Wos, D.O.); CentraCare Clinic, St. Cloud, MN 56301 (Harold E. Windschitl, M.D.); Altru Health Systems, Grand Forks, ND 58201 (Tudor Dentchev, M.D.); Sioux Community Cancer Consortium, Sioux Falls, SD 57105 (Loren K. Tschetter, M.D.); Saskatchewan Cancer Foundation, CANADA S7N 4H4 (Muhammad Salim, M.D.); Rapid City Regional Oncology Group, Rapid City, SD 59709 (Larry P. Ebbert, M.D.); Scottsdale CCOP, Scottsdale, AZ 8525 (Tom Fitch, M.D.); Carle Cancer Center CCOP, Urbana, IL 61801 (Kendrith Rowland, M.D); Ochsner Community Clinical Oncology Program, New Orleans, LA 70121 (Carl G. Kardinal, M.D.); Iowa Oncology Research Association CCOP, Des Moines, IA 50309-1014 (Roscoe F. Morton, M.D.).

Author information

Affiliations

  1. Mayo Clinic and Mayo Foundation, Rochester, MN, USA

    James N. Ingle, Vera J. Suman, Thomas M. Pisansky, Lester E. Wold, John H. Donohue & Matthew P. Goetz

  2. Creighton University, University of Nebraska Medical Center and Associates, Omaha, NE, USA

    James A. Mailliard

  3. Illinois Oncology Research Association CCOP, Peoria, IL, USA

    John W. Kugler

  4. Duluth Community Clinical Oncology Program, Duluth, MN, USA

    James E. Krook

  5. Siouxland Hematology–Oncology Associates, Sioux City, IA, USA

    John C. Michalak

  6. Mayo Clinic Jacksonville, Jacksonville, FL, USA

    Edith A. Perez

  7. Mayo Clinic, 200 First Street SW, Rochester, MN, USA

    James N. Ingle

Authors
  1. James N. Ingle
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  2. Vera J. Suman
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  3. James A. Mailliard
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  4. John W. Kugler
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  5. James E. Krook
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  6. John C. Michalak
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  7. Thomas M. Pisansky
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  8. Lester E. Wold
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  9. John H. Donohue
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  10. Matthew P. Goetz
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  11. Edith A. Perez
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Corresponding author

Correspondence to James N. Ingle.

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Ingle, J.N., Suman, V.J., Mailliard, J.A. et al. 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. Breast Cancer Res Treat 98, 217–222 (2006). https://doi.org/10.1007/s10549-005-9152-1

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  • DOI: https://doi.org/10.1007/s10549-005-9152-1

Keywords

  • adjuvant therapy
  • combination hormonal therapy
  • early breast cancer