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. - GBG 54 - MALE
- Conditions
- Breast Cancer in Male PatientsMedDRA version: 19.0Level: PTClassification code 10061020Term: Breast cancer maleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-015122-11-DE
- Lead Sponsor
- GBG Forschungs GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 48
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 (enrolment possible in neoadjuvant, adjuvant and metastatic situation).
7. no target lesion necessary for metastatic situation
8. Positive hormone receptor status (e.g. ER and/or PR-receptor positive).
9. Completed staging prior randomisation (within 8 weeks after diagnose or last therapy (operation, chemotherapy or radiation): 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.
10. 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.
11. Normal cardiac function must be confirmed by ECG within three months prior to randomisation.
12. Laboratory requirements (= 14 days before therapy start):
Hematology
- Hemoglobin = 9 g/dL,
- Leukocytes 4 - 10 x103/µL,
- Thrombocytes 150 - 400 x103/µL.
Hepatic function
- ASAT (SGOT) or ALAT (SGPT) = 2x UNL,
- Total bilirubin = 2x UNL.
Renal function
- Serum creatinine = 1.5x UNL,
- Creatinine clearance > 30mL/min (if creatinine is above UNL, according to Cockroft-Gault).
- 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): analysis has to be done
13. Two serum samples (5 mL) centrally made available.
14. Paraffin tumor tissue block and full blood sample centrally made available (except when the patient does not agree to central biomaterial collection).
15. The patient must be accessible for treatment.
Patients can simultaneously be registered in the register study of the University Hospital of Magdeburg.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Female patients.
2. Prior endocrine therapy of breast carcinoma.
3. Known or suspected hypersensitivity reaction to the compounds or incorporated substances.
4. No indication for endocrine treatment.
5. Life expectancy of less than six months.
6. International Prostate Symptom Score (IPSS) > 17.
7. Prostate carcinoma
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 (except for thromboembolic events correlated to implanted devices (e.g. port thrombosis)).
11. Currently active hepatitis.
12. Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the estradiol suppression between the three treatment arms after three months.;Secondary Objective: To determine the estradiol suppression between the three treatment arms after six months<br>To compare the compliance in the three treatment arms.<br>To compare the efficacy in terms of overall response (for neoadjuvant and metastatic patients) in the three treatment arms.<br>To compare testosterone, dihydrotestosterone (DHT), SHBG, FSH, LH, osteocalcin and CTX in the three treatments arms.To determine the safety and side effect parameters (at every visit):<br>- PSA and hemoglobin.<br>- Lipids (total cholesterol, high density lipid cholesterol, <br> low density lipid cholesterol).<br>- Questionnaires AMS, IIEF, IPSS.<br>- Adverse events according to NCI-CTCAE version 4.0.<br>Translational research.;Primary end point(s): Estradiol suppression between the three treatment arms after three months.;Timepoint(s) of evaluation of this end point: After three months of study treatment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To determine the estradiol suppression between the three treatment arms after six months<br>To compare the compliance in the three treatment arms.<br>To compare the efficacy in terms of overall response (for neoadjuvant and metastatic patients) in the three treatment arms.<br>To compare testosterone, dihydrotestosterone (DHT), SHBG, FSH, LH, osteocalcin and CTX in the three treatments arms.;Timepoint(s) of evaluation of this end point: After six months of study treatment.