MALE
Estradiol suppression in neo-/ adjuvanten and palliativen therapy in male beast cancer patients
Introduction - MALE
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).
Study code: MALE / GBG51, EudraCT number 2009-015122-11
News - MALE
The MALE-trial is planned.
Expected start of recruitment: Q-I 2012.
Patienten numbers:
It is planned to conduct the study with 48 patients from approximately 35 sites in Germany.
Other trials:
Please register male breast canvcer patient at the register study of the University Magdeburg. It is possible to participate on both studys simultanusly.
Design - MALE
Prospective, randomised, multi-centre, phase II.
Patients will be randomised in a three-arm design to receive one of the following:
- Arm A: Tamoxifen 20 mg (standard therapy)
- Arm B: Tamoxifen 20 mg + GnRH analogue
- Arm C: Aromatase inhibitor (Exemestane 25 mg) + GnRH analogue.
All treatment will be for six months. Further treatment according to AGO guidelines.
The standardised determination of hormone levels at baseline, after three and six months of treatment will be measured in a central laboratory.
Primary Objective
To determine the estradiol suppression between the three treatment arms after three months.
Unterlagen - MALE
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Contact - MALE
GBG Forschungs GmbH, Neu-Isenburg
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Fax: 06102 / 7480-440
Project Management
Dr. Mathias Uhlig
Tel: 06102 / 7480-421
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