Clinical Trial: Tamoxifen +/- GnRH Analogue vs Aromatase Inhibitor + GnRH Analogue in Male Breast Cancer Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Randomised, Multi-centre Phase II Study Evaluating the Adjuvant, Neoadjuvant or Palliative Treatmant With Tamoxifen +/- GnRH Analogue Versus Aromatase Inhibitor + GnRH Analogue in

Brief Summary: A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in male breast cancer patients (MALE).

Detailed Summary:

Breast cancer in men is a rare disease with approximately 0.5- 1% of all breast cancer cases. Each year, about 400 to 450 cases are diagnosed in Germany. Men tend to present with more advanced disease than women, probably due to the lack of awareness of male breast cancer from both, the patient and the physicians.

Therefore, at presentation they usually have lump or nipple inversion, and more than 40% of the patients have a stage III or IV disease. The great majority of patients have an invasive ductal (90%), hormone receptor positive (90%), HER2 negative (90%) tumor.

The only available information on adjuvant therapies derives from few retrospective cases and retrospective studies with a little number of cases. Therefore, treatment strategies are not based on data from prospective, randomised clinical studies, and optimal treatment is unknown. As a result, current clinical management is generally extrapolated from principles established for the treatment of female breast carcinoma. As the majority of male breast cancer patients have a hormone receptor positive tumor, they receive tamoxifen 20 mg for five years as standard endocrine adjuvant therapy. A lot of withdrawals from the treatment were documented in male breast cancer due to side-effects under tamoxifen therapy. Furthermore, the clinical outcome of tamoxifen-treated male breast cancer patients may be influenced by the activity of cytochrome P450 2D6 enzymes that catalyse the formation of anti-estrogenic metabolites endoxifen and 4-hydroxy-tamoxifen. Therefore a significant proportion of poor to moderate metaboliser is proposed to do not benefit from adjuvant tamoxifen therapy.

Although women benefit from adjuvant treatment with aromatase inhibitors (AI) regarding disease-free-survival, overall survival and treatmen
Sponsor: German Breast Group

Current Primary Outcome: Estradiol blood concentation [ Time Frame: 3 months. ]

To determine the estradiol suppression between the three treatment arms after three months.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Estradiol blood concentration [ Time Frame: 6 months. ]
    To determine the estradiol suppression between the three treatment arms after six months.
  • Compliance [ Time Frame: 6 months. ]
    To compare the compliance in the three treatment arms.
  • Efficacy [ Time Frame: 6 months. ]
    To compare the efficacy in terms of overall response (for neoadjuvant and metastatic patients) in the three treatment arms.
  • Efficacy perameters [ Time Frame: 6 months. ]
    To compare testosterone, dihydrotestosterone (DHT), SHBG, FSH, LH, osteocalcin and CTX in the three treatments arms.
  • Safety and side effect parameters [ Time Frame: 6 months. ]

    To determine the safety and side effect parameters (at every visit):

    • PSA and hemoglobin.
    • Lipids (total cholesterol, high density lipid cholesterol, low density lipid cholesterol).


Original Secondary Outcome: Same as current

Information By: German Breast Group

Dates:
Date Received: July 9, 2012
Date Started: August 2012
Date Completion: March 2018
Last Updated: February 9, 2016
Last Verified: February 2016