Breast Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

99

Study ID:

NCT02258464

Recruitment Status:

Terminated

Sponsor:

Bayer

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There are 68 Locations for this study

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Bakersfield California, 93309, United States

La Jolla California, 92093, United States

Aurora Colorado, 80045, United States

New Haven Connecticut, 06520, United States

Cedar Rapids Iowa, 52403, United States

Annapolis Maryland, 21401, United States

Ann Arbor Michigan, 48109, United States

Pontiac Michigan, 48341, United States

Saint Louis Missouri, 63110, United States

Pittsburgh Pennsylvania, 15213, United States

Houston Texas, 77230, United States

Linz Oberösterreich, 4020, Austria

Innsbruck , 6020, Austria

Winnipeg Manitoba, R3E 0, Canada

London Ontario, N6A 4, Canada

Newmarket Ontario, L3Y 2, Canada

Toronto Ontario, M5G 2, Canada

Ostrava , 708 5, Czechia

Praha 2 , 12808, Czechia

Copenhagen , 2100, Denmark

Herlev , 2730, Denmark

Helsinki , 00290, Finland

Tampere , FIN-3, Finland

Angers Cedex , 49055, France

Saint Cloud , 92210, France

Tübingen Baden-Württemberg, 72076, Germany

Bonn Nordrhein-Westfalen, 53105, Germany

Essen Nordrhein-Westfalen, 45147, Germany

Kowloon , , Hong Kong

Cork , , Ireland

Dublin , 7, Ireland

Afula , 18341, Israel

Haifa , 31096, Israel

Jerusalem , 91031, Israel

Jerusalem , 91120, Israel

Kfar Saba , 44281, Israel

Ramat Gan , 52620, Israel

Tel Aviv , 64239, Israel

Zerifin , 70300, Israel

Busan , 49241, Korea, Republic of

Daegu , 42601, Korea, Republic of

Incheon , , Korea, Republic of

Seoul , 03080, Korea, Republic of

Seoul , 05505, Korea, Republic of

Seoul , 120-7, Korea, Republic of

Nieuwegein , 3435 , Netherlands

Zwolle , 8025 , Netherlands

Oslo , 0424, Norway

Bialystok , 15-02, Poland

Gdynia , 81-51, Poland

Warszawa , 02-78, Poland

Singapore , 11907, Singapore

L'Hospitalet de Llobregat Barcelona, 08907, Spain

A Coruña , 15009, Spain

Barcelona , 08025, Spain

Barcelona , 08036, Spain

Madrid , 28033, Spain

Madrid , 28040, Spain

Madrid , 28041, Spain

Málaga , 29010, Spain

Sevilla , 41071, Spain

Zaragoza , 50009, Spain

Aarau Aargau, 5001, Switzerland

Taipei , 11217, Taiwan

Plymouth Devon, PL6 8, United Kingdom

Northwood Middlesex, HA6 2, United Kingdom

Nottingham Nottinghamshire, NG5 1, United Kingdom

Taunton Somerset, TA1 5, United Kingdom

Cottingham , HU16 , United Kingdom

Merseyside , CH63 , United Kingdom

Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

99

Study ID:

NCT02258464

Recruitment Status:

Terminated

Sponsor:


Bayer

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