Breast cancer (female) - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Bayer

Recruitment countries:

Austria, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States

Health condition studied:

Breast Neoplasms

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: Everolimus
Drug: Exemestane
Drug: Placebo (saline)
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Women (=18 years of age) with metastatic breast cancer not amenable to curative
  treatment by surgery or radiotherapy.
  
  - Documentation of histological or cytological confirmation of estrogen receptor
  positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.
  
  - Documentation of menopausal status: postmenopausal subjects are eligible
  pre-menopausal subjects with ovarian radiation or concomitant treatment with an LH-RF
  agonist/antagonist must have a plasma/serum estradiol assay of <20 pg/mL at screening
  within 7 days prior to randomization. Negative pregnancy test is also required at
  screening. Agreement to use adequate method of contraception as recommended by their
  treating physician.
  
  - Subjects with bone dominant disease with at least 2 skeletal metastases identified at
  baseline by bone scintigraphy and confirmed by computed tomography (CT)/magnetic
  resonance imaging (MRI).
  
  - Subjects must have received at least one line of hormonal therapy in the metastatic
  setting.
  
  - Subjects who are eligible as per the Investigator's assessment and according to the
  local label for treatment with exemestane and everolimus as a second line or greater
  of hormone therapy in a metastatic setting.
  
  - Subjects must have experienced recurrent/progressive disease following treatment with
  a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or
  metastatic setting
  
  - Subjects must have experienced no more than two skeletal-related events (SREs) prior
  to study entry defined as: external beam radiotherapy (EBRT) for bone pain,
  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 bisphosphonates or denosumab for at least 1 month
  before start of study treatment.
  
  - Asymptomatic or mildly symptomatic breast cancer.
  
  - Adequate hematological, liver and kidney function
  
  Exclusion Criteria:
  
  - Subjects with any of the following cancers:
  
  - Inflammatory breast cancer
  
  - Bilateral breast cancer or a history of 2 distinct breast cancers.
  
  - Patients with immediately life-threatening visceral disease for whom chemotherapy is
  preferred treatment option
  
  - 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 provided it was
  administered at least 1 year prior to study entry.
  
  - Subjects who received prior treatment or are already receiving everolimus treatment
  prior to study entry are not eligible
  
  - 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.
  

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

Primary outcomes:

Symptomatic skeletal event free survival (SSE-FS)

Secondary outcomes:

Frequency of abnormalities in Adverse Events
Frequency of abnormalities in laboratory examinations
Frequency of abnormalities in new primary malignancies
Overall survival
Radiological progression-free survival (rPFS)
Time to cytotoxic chemotherapy
Time to opiate use for cancer pain
Time to pain progression

Target sample size:

311

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Contacts:

• Name: Bayer Clinical Trials Contact
• Address:
• Phone:
• Email: clinical-trials-contact@bayerhealthcare.com
• Affiliation:

• Name: Bayer Study Director
• Address:
• Phone:
• Email:
• Affiliation: Bayer

Technical details

Scientific title:

A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT02258451

Secondary ID:

17096
2014-002114-23

Register:

ClinicalTrials.gov

Date of registration:

30/09/2024

Date of first enrollment:

June 2015

Last refreshed:

26 October 2024