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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02258464
• Date of registration: 30/09/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: 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
• Scientific title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy
• Date of first enrolment: March 2, 2015
• Target sample size: 99
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02258464
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Canada, China, Czech Republic, Czechia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Korea, Republic of, Netherlands, Norway, Poland, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Other: Background hormonal therapy

Drug: Placebo (saline)

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Primary Outcome(s)

Symptomatic Skeletal Event Free Survival (SSE-FS) [Time Frame: Up to approximately 51 months]

Secondary Outcome(s)

Number of Participants With Treatment-emergent Adverse Events [Time Frame: Up to approximately 7 months]

Number of Participants With Post-treatment Adverse Events Including Additional Malignancies and Chemotherapy Related Adverse Events [Time Frame: From 30 days after the last dose of study treatment until the end of study, assessed up to approximately 44 months]

Radiological Progression-free Survival (rPFS) [Time Frame: Up to approximately 51 months]

Time to Pain Progression [Time Frame: Up to approximately 51 months]

Overall Survival [Time Frame: Up to approximately 51 months]

Time to Opiate Use for Cancer Pain [Time Frame: Up to approximately 51 months]

Pain Improvement Rate [Time Frame: Up to approximately 51 months]

Time to Cytotoxic Chemotherapy [Time Frame: Up to approximately 51 months]

Secondary ID(s)

16298

2014-002113-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02258464