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Phase 3
18 Years
85 Years
Open (Enrolling)
Male Breast Cancer

Thank you

Trial Information

Inclusion Criteria:

1. Written informed consent for all study procedures.

2. Complete baseline documentation sent to GBG Forschungs GmbH.

3. Male patients.

4. Age ≥ 18 years.

5. Karnofsky-Index ≥ 60%.

6. Histologically confirmed unilateral or bilateral carcinoma or DCIS of the breast at
primary diagnosis (enrolment possible in neoadjuvant, adjuvant and metastatic

7. Positive hormone receptor status (e.g. ER and/or PR-receptor positive).

8. Completed staging prior randomisation (≤ 28 days, minimum: chest X-ray, ultrasound of
the liver, bone scan).

In case of positive findings, further investigations are required to verify the
findings as clinically indicated.

9. Prior chemotherapy is possible. In case of adjuvant treatment: adequate surgical
treatment with histological complete resection including axillary lymph nodes if
patients are included as adjuvant treatment. A sentinel lymph node biopsy is possible
if the sentinel is not involved.

10. Normal cardiac function must be confirmed by ECG within three months prior to

11. Laboratory requirements (≤ 7 days before therapy start):


- Hemoglobin ≥ 9 g/dL,

- Leukocytes 4 - 10 x103/µL,

- Thrombocytes 150 - 400 x103/µL. Hepatic function

- ASAT (SGOT) or ALAT (SGPT) ≤ 1.5x UNL,

- Total bilirubin ≤ 1.5x UNL. Renal function

- Serum creatinine ≤ 1.5x UNL,

- Creatinine clearance > 30mL/min (if creatinine is above UNL, according to

- Cholesterol 200 - 240 mg/dL (5.18 - 6.22 mmol/L),

- HDL cholesterol > 40 mg/dL (> 1 mmol/L),

- LDL cholesterol ≤ 160 mg/dL (≤ 4 mmol/L).

- Prostate specific antigen (PSA) ≤ 2.5 ng/mL.

12. Two serum samples (5 mL) centrally made available.

13. Paraffin tumor tissue block and full blood sample centrally made available (except
when the patient does not agree to central biomaterial collection).

14. The patient must be accessible for treatment.

Exclusion Criteria:

1. Female patients.

2. Prior endocrine therapy of breast carcinoma.

3. Known or suspected hypersensitivity reaction to the compounds or incorporated

4. No indication for endocrine treatment.

5. Life expectancy of less than six months.

6. International Prostate Symptom Score (IPSS) > 17.

7. Prostate carcinoma or PSA > 2.5 ng/mL.

8. History of prostate cancer within the last five years and regardless the time frame
all patients with hormone receptor positive prostate carcinoma who have received
endocrine treatment.

9. Concurrent neuronal or cardiac disease, poorly controlled arterial hypertension.

10. Previous thromboembolic event within the last five years.

11. Currently active hepatitis.

12. Disease significantly affecting gastrointestinal function, e.g. malabsorption
syndrome, resection of the stomach or small bowel, ulcerative colitis.

13. Concurrent treatment with other experimental drugs or participation in another
clinical trial with any investigational, not marketed drug within 30 days prior to
study entry.

14. Patients who are not able to give informed consent as defined according to AMG
(German Drug Law).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estradiol blood concentation

Outcome Description:

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

Outcome Time Frame:

3 months.

Safety Issue:


Principal Investigator

Sibylle Loibl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

GBG Forschungs GmbH


Bundesinstitut für Arzneimittel und Medizinprodukte Bonn: Deutschland

Study ID:

GBG 54



Start Date:

August 2012

Completion Date:

March 2015

Related Keywords:

  • Male Breast Cancer
  • Male breast cancer
  • neoadjuvant, adjuvant or metastatic situation
  • anti-hormonal therapy
  • Breast Neoplasms
  • Breast Neoplasms, Male