NCT01638247

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

5.8 years

First QC Date

July 9, 2012

Last Update Submit

September 18, 2018

Conditions

Male Breast Cancer

Keywords

Male breast cancerneoadjuvant, adjuvant or metastatic situationanti-hormonal therapy

Outcome Measures

Primary Outcomes (1)

  • Estradiol blood concentation

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

    3 months.

Secondary Outcomes (5)

  • Estradiol blood concentration

    6 months.

  • Compliance

    6 months.

  • Efficacy

    6 months.

  • Efficacy perameters

    6 months.

  • Safety and side effect parameters

    6 months.

Study Arms (3)

Tamoxifen

ACTIVE COMPARATOR

Tamoxifen alone (daily).

Drug: Tamoxifen

Tamoxifen and GnRH analogue

EXPERIMENTAL

Tamoxifen (daily) + GnRH analogue (at randomisation and after three months).

Drug: Tamoxifen and GnRH analogue

Exemestane and GnRH analogue

EXPERIMENTAL

Exemestane (daily) + GnRH analogue (at randomisation and after three months).

Drug: Exemestane and GnRH analogue

Interventions

TamoxifenDRUG

25 mg daily.

Tamoxifen
Tamoxifen and GnRH analogueDRUG

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).

Also known as: TRENATONE, ZOLADEX
Tamoxifen and GnRH analogue
Exemestane and GnRH analogueDRUG

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).

Also known as: AROMASIN, TRENATONE, ZOLADEX.
Exemestane and GnRH analogue

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent for all study procedures.
  • Complete baseline documentation sent to GBG Forschungs GmbH.
  • Male patients.
  • Age ≥ 18 years.
  • Karnofsky-Index ≥ 60%.
  • Histologically confirmed unilateral or bilateral carcinoma or of the breast at primary diagnosis (enrolment possible in neoadjuvant, adjuvant and metastatic situation).
  • : 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), 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.
  • \. 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.
  • \. Normal cardiac function must be confirmed by ECG within three months prior to randomisation.
  • \. Laboratory requirements (≤ 14 days before therapy start): Hematology
  • Hemoglobin ≥ 9 g/dL,
  • Leukocytes 4 - 10 x1000/µL,
  • Thrombocytes 150 - 400 x1000/µL. Hepatic function
  • ASAT (SGOT) or ALAT (SGPT) ≤ 2x UNL,
  • +8 more criteria

You may not qualify if:

  • Female patients.
  • Prior endocrine therapy of breast carcinoma.
  • Known or suspected hypersensitivity reaction to the compounds or incorporated substances.
  • No indication for endocrine treatment.
  • Life expectancy of less than six months.
  • International Prostate Symptom Score (IPSS) \> 17.
  • Current diagnosis of a Prostate carcinoma.
  • 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.
  • Concurrent neuronal or cardiac disease, poorly controlled arterial hypertension.
  • Previous thromboembolic event within the last five years (except from thromboembolic events correlated to implanted devices (e.g. port thrombosis)
  • Currently active hepatitis.
  • Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel.
  • 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.
  • Patients who are not able to give informed consent as defined according to AMG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Location

Related Publications (1)

  • Reinisch M, Seiler S, Hauzenberger T, Kamischke A, Schmatloch S, Strittmatter HJ, Zahm DM, Thode C, Furlanetto J, Strik D, Mobus V, Reimer T, Sinn BV, Stickeler E, Marme F, Janni W, Schmidt M, Rudlowski C, Untch M, Nekljudova V, Loibl S. Efficacy of Endocrine Therapy for the Treatment of Breast Cancer in Men: Results from the MALE Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):565-572. doi: 10.1001/jamaoncol.2020.7442.

    PMID: 33538790DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms, Male

Interventions

TamoxifenGonadotropin-Releasing HormoneGoserelinexemestane

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Mattea Reinisch, MD

    Kliniken Essen-Mitte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

DE(1)