OncoMatch/Clinical Trials/NCT05362760
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
Is NCT05362760 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Abemaciclib + Aromatase Inhibitor and Abemaciclib + Fulvestrant for hormone receptor-positive metastatic breast cancer.
Treatment: Abemaciclib + Aromatase Inhibitor · Abemaciclib + Fulvestrant — The MINERVA Trial aims to evaluate safety, efficacy and quality of life (QoL) for the combination of Abemaciclib with an Aromatase Inhibitor or Fulvestrant in pre- and postmenopausal patients with metastatic hormone receptor positive HER2 negative breast cancer in the first line setting. Side effect monitoring and patient reported outcomes will be captured using the web- and app-based CANKADO digital health application. Via this user-friendly tool the patients can document their therapy side effects (e.g. diarrhea) and outcomes on a day-to-day basis. The capturing of side effects using the digital health application will be done additionally to the regular AE documentation. Furthermore, translational research objectives of this trial include the investigation of biomarkers (ct-DNA, germline DNA) to evaluate whether they can give insights into the reasons for response, intrinsic or acquired resistance to the combined endocrine
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (IHC positive as per ASCO/CAP guidelines)
a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (estrogen receptor [ER], progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
Required: PR (PGR) overexpression (IHC positive as per ASCO/CAP guidelines)
a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (estrogen receptor [ER], progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
Required: HER2 (ERBB2) wild-type (no overexpression by IHC or ISH as per ASCO/CAP guidelines)
a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization (ISH) as defined in the relevant ASCO/CAP guidelines
Disease stage
Metastatic disease required
locally advanced recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant/neoadjuvant chemotherapy allowed; prior chemotherapy in metastatic setting excluded
Prior treatment with chemotherapy in the metastatic setting
Cannot have received: endocrine therapy
Exception: first line endocrine therapy for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry
endocrine therapy in the metastatic setting (except for first line endocrine therapy in metastatic or locally advanced disease for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)
Cannot have received: CDK4/6 inhibitor (abemaciclib, ribociclib, palbociclib)
Exception: first-line CDK4/6 inhibitor (ribociclib/palbociclib) in metastatic setting allowed only if terminated due to toxicity after max 3 months and no progression occurred before study entry; prior CDK4/6 inhibitor in neo-/adjuvant setting is allowed
Prior treatment with a CDK4/6 inhibitor for metastatic or locally advanced disease (first-line treatment with a CDK 4/6 inhibitor (Ribociclib/Palbociclib) in the metastatic setting is allowed only if terminated due to toxicity after max 3 months and no progression occurred before study entry. Prior treatment with a CDK 4/6 inhibitor in the neo-/adjuvant setting is allowed.)
Cannot have received: systemic anti-cancer therapy
Exception: except for first-line endocrine therapy in metastatic or locally advanced disease (see above)
Prior systemic anti-cancer therapy within the last 21 days prior to start of trial treatment except for first-line endocrine therapy in metastatic or locally advanced disease (see above)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L, Platelet count ≥ 100 × 10^9/L, Hemoglobin ≥ 8 g/dL
Kidney function
Serum Creatinine ≤ 2.0 mg/dl or 177µmol/L
Liver function
ALT and AST ≤ 2.0 × ULN (≤ 3 x ULN in case of liver metastases), Total Bilirubin ≤ 1.5 × ULN (with Gilbert's syndrome max. 2 x ULN)
adequate bone marrow and organ function evidenced by the following laboratory results: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, Platelet count ≥ 100 × 10^9/L, Hemoglobin ≥ 8 g/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN (≤ 3 x ULN in case of liver metastases), Total Bilirubin ≤ 1.5 × ULN (with Gilbert's syndrome max. 2 x ULN), Serum Creatinine ≤ 2.0 mg/dl or 177µmol/L, Coagulation: International Normalized Ratio (INR) ≤ 1,5
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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