Trials Sponsors Conditions Drugs Pricing

Conditions

Bone Metastases Metastatic Breast Cancer Metastatic Prostate Cancer

Keywords

metastatic breast cancercastration resistant metastatic prostate cancerbone metastasesDenosumabXGEVAde-escalation

Outcome Measures

Primary Outcomes (1)

Time to first on-trial symptomatic skeletal event (SSE; Clinically significant pathological fracture, radiation therapy to bone, surgery to bone or spinal cord compression).
A SSE is defined as one of the following events: Clinically significant pathological fracture, radiation therapy to bone, surgery to bone, or spinal cord compression.
at the latest 5 years after randomization.

Secondary Outcomes (8)

Toxicity (focus on hypocalcaemia and osteonecrosis of the jaw)
at the latest 5 years after randomization.
Time to first and subsequent on-trial SSE
at the latest 5 years after randomization.

Study Arms (2)

Arm A (standard arm)

ACTIVE COMPARATOR

Denosumab 120mg (XGEVA®) sc. q4w

Drug: Denosumab (standard dosing)

Arm B (reduced arm)

EXPERIMENTAL

Denosumab 120mg (XGEVA®) sc. q4w \[weeks 1, 5, 9\] followed by Denosumab 120mg (XGEVA®) sc. q12w \[weeks 13, 25, …\]

Drug: Denosumab (reduced dosing)

Interventions

Denosumab (reduced dosing)Drug

3x Denosumab 120mg (XGEVA®) sc. q4w followed by Denosumab 120mg (XGEVA®) sc. q12w

Also known as: XGEVA®

Arm B (reduced arm)

Denosumab (standard dosing)Drug

Denosumab 120mg (XGEVA®) sc. q4w

Also known as: XGEVA®

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient has given written informed consent.
Histologically confirmed diagnosis of breast or prostate cancer before randomization.

Sponsors & Collaborators

Swiss Cancer Institute
Otherlead

Study Sites (50)

Landeskrankenhaus Feldkirch

Feldkirch, 6800, Austria

Klinikum Wels-Grieskrichen GmbH

Wels, 4600, Austria

Uniklinik Düsseldorf, Urologische Klinik

Düsseldorf, 40225, Germany

Universitätsklinikum Düsseldorf, Frauenheilkunde/Geburtshilfe

Düsseldorf, 40225, Germany

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Universitäts-Frauenklinik Ulm

Ulm, 89075, Germany

Related Publications (1)

Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVED

MeSH Terms

Conditions

Breast NeoplasmsProstatic Neoplasms

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic Diseases

Study Officials

Roger von Moos, PD MD
Kantonsspital Graubünden
STUDY CHAIR
Arnoud Templeton, MD
Cantonal Hospital of St. Gallen
STUDY CHAIR
Silke Gillessen, Prof
Cantonal Hospital of St. Gallen
STUDY CHAIR
Andreas Müller, MD
Kantonsspital Winterthur KSW
STUDY CHAIR

Enrollment

1,380 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 31, 2014

Study Start

July 16, 2014

Actual (reported)

Study Stopped

Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Arm A (standard arm)

Arm B (reduced arm)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (50)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Arm A (standard arm)

Arm B (reduced arm)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (50)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations