Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

March 2, 2015

Primary Completion Date

August 13, 2019

Study Completion Date

August 13, 2019

Conditions
Breast Neoplasms
Interventions
DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update)

DRUG

Placebo (saline)

Up to 6 cycles of saline injection

OTHER

Background hormonal therapy

Prescribed by PI and was provided as long as patient can tolerate treatment. It must be prescribed as per local label in country participating.

Trial Locations (71)

7

Dublin

2100

Copenhagen

2730

Herlev

4020

Linz

5001

Aarau

6020

Innsbruck

11217

Taipei

12808

Prague

15009

A Coruña

21401

Annapolis

28033

Madrid

28040

Madrid

28041

Madrid

29010

Málaga

41071

Seville

42601

Daegu

45147

Essen

48109

Ann Arbor

48341

Pontiac

49055

Angers

49241

Busan

50009

Zaragoza

52403

Cedar Rapids

53105

Bonn

63110

St Louis

64239

Tel Aviv

72076

Tübingen

77230

Houston

80045

Aurora

92093

La Jolla

92210

Saint-Cloud

93309

Bakersfield

119074

Singapore

1834111

Afula

3109601

Haifa

4428164

Kfar Saba

5262000

Ramat Gan

7030000

Ẕerifin

9103102

Jerusalem

9112001

Jerusalem

06520

New Haven

15213-3180

Pittsburgh

R3E 0V9

Winnipeg

N6A 4L6

London

L3Y 2P9

Newmarket

M5G 2M9

Toronto

708 52

Ostrava

00290

Helsinki

FIN-33520

Tampere

Unknown

Kowloon

Cork

Incheon

3435 CM

Nieuwegein

8025 AB

Zwolle

0424

Oslo

15-027

Bialystok

81-519

Gdynia

02-781

Warsaw

03080

Seoul

05505

Seoul

120-752

Seoul

08907

L'Hospitalet de Llobregat

08025

Barcelona

08036

Barcelona

PL6 8DH

Plymouth

CH63 4JY

Merseyside

HA6 2RN

Northwood

NG5 1PB

Nottingham

TA1 5DA

Taunton

HU16 5JQ

Cottingham

S10 2SJ

Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02258464 - Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter