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

NCT01638247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-09-19

No results posted yet for this study

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).

Conditions

  • Male Breast Cancer

Interventions

DRUG

Tamoxifen

25 mg daily.

DRUG

Tamoxifen and GnRH analogue

25 mg Tamoxifen daily and GnRH analogue: * Goserelin (10.8 mg s.c. after randomisation and after three months) or * Leuprorelin (11.25 mg s.c. after randomisation and after three months).

DRUG

Exemestane and GnRH analogue

25 mg Exemestane daily and GnRH analogue: * Goserelin (10.8 mg s.c. after randomisation and after three months) or * Leuprorelin (11.25 mg s.c. after randomisation and after three months).

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Mattea Reinisch, MD · Kliniken Essen-Mitte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01638247 on ClinicalTrials.gov