Trial Condition(s):

Breast Neoplasms

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

Bayer Identifier:

16298

ClinicalTrials.gov Identifier:

NCT02258464

EudraCT Number:

2014-002113-39

Terminated/Withdrawn

Trial Purpose

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

Inclusion Criteria
- Documentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.
 - Women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
 - Documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
 - Subjects with bone dominant disease with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI). Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph nodes)and/or visceral metastases  is allowed.
 - Measurable or non-measurable disease (but radiologically evaluable) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
 - Subjects must have received at least one line of hormonal therapy in the metastatic setting
 - Subjects who are eligible for further standard of care endocrine treatment.
 - Subjects enrolled in the current study must start treatment with the single hormone agent  either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo).
 - Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
 - Subjects must be on therapy with bisphosphonate and denosumab. and are required to have been on such therapy for at least 1 month before start of study treatment.
  - Adequate hematological, liver and kidney function.
Exclusion Criteria
- Subjects with Inflammatory breast cancer.
 - Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.
 - Subjects with known or history of brain metastases or leptomeningeal disease: subjects with neurological symptoms must undergo a contrast CT scan or MRI of the brain within 28 days prior to randomization to exclude active brain metastasis. Imaging of the central nervous system (CNS) is otherwise not required.
 - Known presence of osteonecrosis of jaw.
 - Patients with immediately life-threatening visceral disease, for whom chemotherapy is the preferred treatment option. 
 - Lymphangitic carcinomatosis.
 - Patients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.

Trial Summary

Enrollment Goal
99
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kfar Saba, Israel, 4428164

Status
Completed
 
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Investigative Site

Zerifin, Israel, 7030000

Status
Completed
 
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Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
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Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
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Tel Aviv, Israel, 64239

Status
Completed
 
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Afula, Israel, 1834111

Status
Completed
 
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Ramat Gan, Israel, 5262000

Status
Completed
 
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Jerusalem, Israel, 9103102

Status
Completed
 
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Linz, Austria, 4020

Status
Completed
 
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Innsbruck, Austria, 6020

Status
Completed
 
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Sheffield, United Kingdom, S10 2SJ

Status
Completed
 
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Nottingham, United Kingdom, NG5 1PB

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Completed
 
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Ann Arbor, United States, 48109

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Completed
 
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Madrid, Spain, 28033

Status
Completed
 
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Sevilla, Spain, 41071

Status
Terminated
 
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Barcelona, Spain, 08025

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Completed
 
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L'Hospitalet de Llobregat, Spain, 08907

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Completed
 
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Cork, Ireland

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Completed
 
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Gdynia, Poland, 81-519

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Completed
 
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Bialystok, Poland, 15-027

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Completed
 
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Helsinki, Finland, 00290

Status
Completed
 
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Tampere, Finland, FIN-33520

Status
Completed
 
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Essen, Germany, 45147

Status
Terminated
 
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Málaga, Spain, 29010

Status
Completed
 
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Madrid, Spain, 28041

Status
Terminated
 
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Madrid, Spain, 28040

Status
Completed
 
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Barcelona, Spain, 08036

Status
Completed
 
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Zaragoza, Spain, 50009

Status
Terminated
 
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Warszawa, Poland, 02-781

Status
Completed
 
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Cedar Rapids, United States, 52403

Status
Completed
 
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Aurora, United States, 80045

Status
Completed
 
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Pittsburgh, United States, 15213-3180

Status
Terminated
 
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Pontiac, United States, 48341

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Completed
 
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Annapolis, United States, 21401

Status
Completed
 
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New Haven, United States, 06520

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Completed
 
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La Jolla, United States, 92093

Status
Completed
 
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St. Louis, United States, 63110

Status
Completed
 
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Hong kong, Hong Kong, China

Status
Completed
 
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Investigative Site

København, Denmark, 2100

Status
Terminated
 
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Herlev, Denmark, 2730

Status
Terminated
 
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Seoul, South Korea, 03080

Status
Completed
 
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Seoul, South Korea, 05505

Status
Completed
 
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Seoul, South Korea, 03722

Status
Completed
 
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Busan, South Korea, 49241

Status
Completed
 
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Incheon, South Korea

Status
Completed
 
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Tübingen, Germany, 72076

Status
Completed
 
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Bonn, Germany, 53105

Status
Completed
 
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A Coruña, Spain, 15009

Status
Completed
 
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London, Canada, N6A 4L6

Status
Completed
 
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Toronto, Canada, M5G 2M9

Status
Completed
 
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Winnipeg, Canada, R3E 0V9

Status
Terminated
 
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Investigative Site

Oslo, Norway, 0424

Status
Completed
 
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Investigative Site

NIEUWEGEIN, Netherlands, 3435 CM

Status
Completed
 
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SAINT CLOUD, France, 92210

Status
Completed
 
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Taunton, United Kingdom, TA1 5DA

Status
Completed
 
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Investigative Site

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
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Houston, United States, 77230

Status
Completed
 
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Investigative Site

Taipei, Taiwan, China, 11217

Status
Completed
 
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Singapore, Singapore, 119074

Status
Completed
 
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Investigative Site

Cottingham, United Kingdom, HU16 5JQ

Status
Completed
 
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Investigative Site

Aarau, Switzerland, 5001

Status
Terminated
 
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Investigative Site

Dublin, Ireland, 7

Status
Completed
 
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Investigative Site

Newmarket, Canada, L3Y 2P9

Status
Completed
 
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Investigative Site

Ostrava, Czech Republic, 708 52

Status
Completed
 
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Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
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Investigative Site

PLYMOUTH, United Kingdom, PL6 8DH

Status
Completed
 
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Bakersfield, United States, 93309

Status
Completed
 
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Investigative Site

Daegu, South Korea, 42601

Status
Completed
 
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Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
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Investigative Site

ANGERS CEDEX, France, 49055

Status
Completed
 

Trial Design