Information sheet on the clinical trial - MINERVA

Main indication

Breast cancer

 

Study name (study type)

MINERVA Study

Study sponsor

University Hospital Ulm on behalf of the Detect Study Group

Registration number

EudraCT No. 2021-000287-30

FOR RAPID READERS:

National "first-line" Phase IV study to evaluate the safety, efficacy, and quality of life of treatment with abemaciclib plus an aromatase inhibitor or fulvestrant

DETAILED INFORMATION:

The objective of the MINERVA study is to investigate the safety, efficacy, and quality of life of the combination of abemaciclib with an aromatase inhibitor or fulvestrant as first-line treatment for metastatic hormone receptor-positive, HER2-negative breast cancer. 

Study Title

MINERVA Study: Combination of Abemaciclib (Verzenios) and Endocrine Therapy in Patients with Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer with a Focus on Digital Side Effect Management

Which conditions are being treated in this study?

Breast cancer

Are specific subgroups of patients with one of the mentioned conditions being treated?

Patients with HR+/HER2- advanced or metastatic breast cancer  

Background on the study medication

Abemaciclib is approved by the EMA for the treatment of women with HR+ and HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant.

Several studies (MONARCH 2 and 3) have shown that the combination of endocrine therapy with the CDK4/6 inhibitor abemaciclib significantly prolongs progression-free survival and overall survival compared to endocrine therapy alone. 

Study Protocol

Patients are enrolled in combination therapy with abemaciclib and an aromatase inhibitor or fulvestrant. Patients receive the study medication for at least 2 years (unless the study is discontinued early); the response to the medication may vary depending on the patient (maximum study duration: 4 years). 

Inclusion Criteria

• Patients with a primary tumor and/or metastases with histopathologically or immunohistologically confirmed positive hormone receptor status and negative HER2 status 
• Breast cancer with locoregional progression that is not amenable to surgery or radiation therapy with curative intent, or metastatic breast cancer 
• Patients with an indication for endocrine-based therapy in the metastatic setting
• ECOG score < 
• Patients aged 18 years or older
• No prior therapy for metastatic breast cancer
• Patients who have received adjuvant chemotherapy or radiation therapy, with subsequent complete recovery from therapy, and at least 14 days must have elapsed between treatments

Exclusion criteria

• Patients with visceral disease or a life expectancy of < 6 months
• Patients with a known hypersensitivity reaction to abemaciclib 
• Patients already participating in another study
• Patients with various pre-existing conditions (details available upon request)

Your contacts: Investigators at the center and contact information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Phone: 06142 88-1223

Responsible staff members at the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032