Actively Recruiting
Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management. The MINERVA Trial - A Phase IV Trial
Led by Prof. Wolfgang Janni · Updated on 2025-05-16
300
Participants Needed
54
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Prof. Wolfgang Janni
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.
CONDITIONS
Brief Title
Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any trial procedures
- Be reliable and willing to follow the trial procedures and be available for the trial duration
- Female and at least 18 years old
- Diagnosed with hormone receptor-positive, HER2-negative breast cancer
- Have locally advanced recurrent or metastatic disease not suitable for curative surgery or radiation
- Indicated for endocrine-based therapy in the metastatic setting
- Have an ECOG performance status of 0, 1, or 2
- If central nervous system metastases exist, they must be stable and radiotherapy completed over 14 days ago
- Pre- and postmenopausal patients are eligible; women of childbearing potential must use highly effective contraception as specified
- No prior metastatic therapy except up to 3 months of first-line endocrine therapy without progression
- Previous adjuvant endocrine therapy and chemotherapy allowed if recovered
- Adequate bone marrow and organ function as defined by lab tests
- Able to swallow oral medications
- Willing to use the CANKADO digital app to report side effects and outcomes (strongly recommended)
- Negative pregnancy test before trial registration for women of childbearing potential
You will not qualify if you...
- Visceral crisis or life expectancy less than 6 months
- History of hypersensitivity to Abemaciclib or its components
- Prior chemotherapy or endocrine therapy for metastatic disease except allowed first-line endocrine therapy
- Not eligible for endocrine therapy
- Severe uncontrolled systemic, social, or psychiatric conditions interfering with treatment or adherence
- Serious preexisting medical conditions like interstitial lung disease or severe renal impairment
- Prior CDK4/6 inhibitor use in metastatic or locally advanced disease, except limited cases
- Treatment with other investigational agents within 4 weeks or 5 half-lives prior to registration
- History of serious cardiac arrhythmias or sudden cardiac arrest
- Pregnant or lactating females
- Legal incapacity or limited legal capacity
- History of other cancers unless in remission for at least 3 years
- Active systemic bacterial, fungal, or viral infections requiring treatment
- Recent systemic anti-cancer therapy or radiotherapy within specified washout periods
- Major surgery within 14 days prior to registration
Research Team
N
Natalie Uhl
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