The MINERVA study investigates the efficacy and tolerability of Abemaciclib in combination with antihormonal therapy (aromatase inhibitor or Fulvestrant) in patients with locally advanced or metastatic breast cancer (Hormone Receptor +, HER2 -). As part of the study, therapy-related side effects are recorded in a digital patient diary using the free health app CANKADO, processed, and used as a basis for effective, personalized doctor-patient discussions to detect and alleviate symptoms early, thereby improving quality of life. The study includes an additional research project that examines biomarkers in your blood (e.g., tumor components and free tumor cells). The insights gained are intended to help assess the effectiveness of the therapy efficiently and promptly based on blood samples in the future.

What is being investigated in this study?

Abemaciclib is a medication used to treat certain types of breast cancer. It belongs to the group of so-called CDK4/6 inhibitors. CDK4/6 are proteins that play an important role in cell division. In some cancer cells, these proteins are overactive, causing the cells to grow uncontrollably. Abemaciclib inhibits these proteins and can thereby slow down the growth of cancer cells.

Abemaciclib is specifically used to treat hormone receptor-positive, HER2-negative breast cancer. This means that the cancer responds to certain hormones (hormone receptor-positive) and does not have a specific receptor called HER2 on the cell surface (HER2-negative).

The medication is used in combination with other therapies such as aromatase inhibitors or Fulvestrant. These therapies block the production or action of hormones that can promote the growth of cancer cells. Therefore, in the MINERVA study, therapy is carried out with the CDK4/6 inhibitor Abemaciclib in combination with an antihormonal therapy chosen by the physician (aromatase inhibitor or Fulvestrant), according to the approval of Abemaciclib. Thus, the patient always receives a therapy approved and well-studied for this situation.

Check-ups are carried out as part of routine examinations in accordance with guideline recommendations. Additional study-related effort is only required for the documentation of side effects and quality of life questionnaires in the free CANKADO PRO-React app, as well as, if applicable, the collection of blood samples for the translational research project.

What is the goal of the study?

The main focus of this investigation is the calculation of progression-free survival (PFS). Additional goals include the assessment of adverse events (side effects) and the daily documentation of these events through the CANKADO PRO-React health application, including a patient diary and quality of life questionnaires.

CANKADO is a useful digital companion for your breast cancer medication therapy, helping you keep track of your medication intake and your own health. The app combines medical and technical expertise to facilitate communication between doctors and patients and provide effective support during therapy. The parameters recorded in the diary provide a continuous picture of your therapy progress and support your treatment team in preparing for doctor-patient discussions. Extensive reports allow for timely and effective responses to your individual situation. This way, potential side effects can be detected early by the doctor, preventing severe courses. While the use of the app is a focus of the study, it is not mandatory for study participation.

What is the study procedure?

Within the study, there are two treatment arms to which patients are randomly assigned in a 1:1 ratio:

Arm 1:
Abemaciclib daily 2 x 150 mg (oral) + endocrine therapy of choice (aromatase inhibitor/Fulvestrant)

Arm 2:
Abemaciclib + Aromatase Inhibitor (Anastrozole, Letrozole, Exemestane) OR Fulvestrant (possibly GnRH analogues in premenopausal patients)

Are there risks?

You will be informed about possible risks or side effects associated with participation during an informational discussion.

Eligibility Requirements

Women aged 18 and older can participate in this study, with:

• Initial diagnosis of locally advanced or metastatic breast cancer
• Hormone receptor-positive, HER2-negative tumor
• Indication for endocrine-based combination therapy with a CDK4/6 inhibitor

In addition, there are other criteria that must be met for study participation. Interested patients should speak with the investigators at a study center to determine if this study is suitable for them.

Where can I participate in this study?

Further information about the study and participating centers can be found at:
https://www.minerva-studie.de/

This study is conducted by: