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Hormone Receptor-positive Metastatic Breast CancerPhase 4MINERVANCT05362760

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

A Phase 4 study testing Abemaciclib + Aromatase Inhibitor and Abemaciclib + Fulvestrant in people with Hormone Receptor-positive Metastatic Breast Cancer and HER2-negative Metastatic Breast Cancer, run by Prof. Wolfgang Janni at 54 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Abemaciclib + Aromatase Inhibitor and Abemaciclib + Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
54 sitesin 2 countries
Study dates
27 Apr 2022to Apr 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be included in the trial only if they meet all the following criteria:
  • Have given written informed consent prior to any trial-specific procedures
  • Are reliable, willing to be available for the duration of the trial and are willing to follow trial procedures
  • Are female and aged ≥ 18 years
  • Diagnosis of hormone receptor positive (HR+), HER2- breast cancer. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess HR and HER2 status if clinically indicated.
  • To fulfill the requirement for HR+ disease, 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 (Hammond et al. 2010).
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  • To fulfill the requirement of HER2- disease, 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 (Wolff et al. 2013).
  • Have locally advanced recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
  • Indication for endocrine based therapy in the metastatic setting
  • Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • If central nervous system (CNS) metastases are known these have to be stable (radiotherapy finished for more than 14 days ago, no required steroid medication with more than 4 mg Dexamethasone per day)
  • Pre- and postmenopausal patients are allowed. Postmenopausal is defined as no menses for 12 months without an alternative medical cause. Women of Childbearing Potential (WOCBP, defined as not postmenopausal and not surgically or congenitally sterile) whose male partners are potentially fertile (e.g. no vasectomy) must use highly effective contraception methods for the duration of the trial and for at least 3 weeks after last dose of drugs used in the trial.Women of childbearing potential must use highly effective contraception methods for two years after the last dose of fulvestrant. Highly effective birth control methods that results in a failure rate of less than 1% per year include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the patient.
  • No prior therapy for metastatic disease (except for first line endocrine therapy for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)
  • Previous adjuvant endocrine therapy and (neo)adjuvant chemotherapy is allowed
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or ≤ Grade 2 peripheral neuropathy prior to registration. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy).
  • Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration.
  • One of the following as defined by the RECIST v1. 1 (see Attachment 15.5):
  • Measurable disease. At least one measurable lesion assessable using standard techniques by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1). Tumor evaluation according to RECIST version 1.1 (based on local assessment) has to be performed within 28 days before trial registration.
  • Nonmeasurable bone-only disease (must be evaluable, but not necessarily measurable by RECIST). Nonmeasurable bone-only disease may include any of the following: blastic bone lesion, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component.
  • The patient has adequate bone marrow and organ function evidenced by the following laboratory results: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelet count ≥ 100 × 109/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
  • The patient is able to swallow oral medications
  • Willingness to use the provided CANKADO digital health application to report side effects and patient reported outcomes (The use of the CANKADO app is not mandatory for study participation, but is strongly recommended)
  • Negative pregnancy test before trial registration for women of child-bearing potential and highly effective contraception if the risk of conception exists and a negative serum pregnancy test within 7 days after the first dose of trial treatment. Pregnancy tests should be performed in premenopausal patients according to local standard

Who cannot join

  • Patients will be included in the trial only if they meet none of the following criteria:
  • Visceral crisis or life expectancy < 6 months
  • History of hypersensitivity reactions attributed to Abemaciclib or to other components of drug formulation
  • Prior treatment with chemotherapy in the metastatic setting or 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)
  • Patient not eligible for endocrine based therapy
  • Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol
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  • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this trial (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • 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.)
  • 8. Treatment with any other investigational agents within four weeks or 5 half-lives prior to trial registration, whichever is longer
  • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Females who are pregnant or lactating
  • Legal incapacity or limited legal capacity
  • History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
  • The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating trial treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
  • 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)
  • Radiotherapy within the last 14 days prior to registration
  • Patient has had major surgery within 14 days prior to trial registration.

Trial locations and contacts

54 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Natalie Uhl contact

+49 731 500 58652

natalie.uhl@uniklinik-ulm.de

54 sites in 2 countries

Germany52 sites, 52 recruiting

  • Kliniken Ostalb gkAöR

    Aalen

    Recruiting

  • Klinikum St. Marien Kommunalunternehmen - AöR Der Stadt Amberg

    Amberg

    Recruiting

  • Klinikum Aschaffenburg-Alzenau gGmbH

    Aschaffenburg

    Recruiting

  • Gemeinschaftspraxis Dr. Heinrich / Dr. Bangerter

    Augsburg

    Recruiting

  • Universitätsklinikum Augsburg A.d.ö.R

    Augsburg

    Recruiting

  • MediOnko-Institut GbR

    Berlin

    Recruiting

  • Hämatologikum Biberach

    Biberach

    Recruiting

  • Gynäkologisches Zentrum Bonn - Friedensplatz

    Bonn

    Recruiting

  • Studien GbR Braunschweig

    Braunschweig

    Recruiting

  • Hämato-Onkologische Praxis im Medicum

    Bremen

    Recruiting

  • St. Elisabeth-Krankenhaus GmbH

    Cologne

    Recruiting

  • Onkologisches Zentrum Donauwörth

    Donauwörth

    Recruiting

  • Gemeinschaftspraxis

    Dresden

    Recruiting

  • Onkozentrum Dresden

    Dresden

    Recruiting

  • MVZ Medical Center Düsseldorf GmbH

    Düsseldorf

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf

    Recruiting

  • Internistische Praxis Ehingen

    Ehingen

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen

    Recruiting

  • St. Antonius-Hospital

    Eschweiler

    Recruiting

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

    Recruiting

  • Krankenhäuser Landkreis Freudenstadt gGmbH

    Freudenstadt

    Recruiting

  • Internistische Gemeinschaftspraxis

    Friedrichshafen

    Recruiting

  • Klinikum Garmisch-Partenkirchen GmbH

    Garmisch-Partenkirchen

    Recruiting

  • Main-Kinzig-Kliniken gGmbH Gelnhausen

    Gelnhausen

    Recruiting

  • Gemeinschaftspraxis und Tagesklinik Halle

    Halle

    Recruiting

  • Albertinen-Krankenhaus

    Hamburg

    Recruiting

  • Sana Klinikum Hameln-Pyrmont

    Hamelin

    Recruiting

  • Frauenärzte am Bahnhofsplatz

    Hildesheim

    Recruiting

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe

    Recruiting

  • Klinikum Kassel GmbH

    Kassel

    Recruiting

  • Klinikverbund Kempten-Oberallgäu gGmbH

    Kempten

    Recruiting

  • Klinikum Konstanz

    Konstanz

    Recruiting

  • ZAGO- Zentrum für ambulante gynäkologische Onkologie

    Krefeld

    Recruiting

  • Krankenhausgesellschaft St. Vincenz mbH

    Limburg

    Recruiting

  • Praxis für gynäkologische Onkologie / Prof. Dr. med. Ulrike Nitz / Raquel von Schumann

    Mönchengladbach

    Recruiting

  • LMU - Klinikum der Universität München

    München

    Recruiting

  • München Klinik gGmbH Harlaching

    München

    Recruiting

  • Kliniken Ostalb gkAöR, Stauferklinikum Schwäbisch Gmünd

    Mutlangen

    Recruiting

  • TZN-Tumorzentrum Niederrhein GmbH

    Neuss

    Recruiting

  • Klinikum Nürnberg Nord

    Nuremberg

    Recruiting

  • medius KLINIK NÜRTINGEN

    Nürtingen

    Recruiting

  • Praxis Dr. Guth

    Plauen

    Recruiting

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam

    Recruiting

  • Klinikum Rheine

    Rheine

    Recruiting

  • GPR Gesundheits- und Pflegezentrum Rüsselsheim gGmbH

    Rüsselsheim am Main

    Recruiting

  • Diakoneo Diak-Klinikum Schwäbisch Hall gGmbH

    Schwäbisch Hall

    Recruiting

  • Clinical Research Stolberg GmbH

    Stolberg

    Recruiting

  • Gynäkologie Kompetenzzentrum Stralsund

    Stralsund

    Recruiting

  • Universitätsfrauenklinik Tübingen

    Tübingen

    Recruiting

  • University Hospital Ulm Gynecology/Obstetrics

    Ulm

    Recruiting

  • St. Josefs-Hospital

    Wiesbaden

    Recruiting

Other trials in Germany

Switzerland2 sites, 2 recruiting

  • Spital Wallis

    Brig

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen

    Recruiting

Other trials in Switzerland

About this study

Official 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. The MINERVA Trial - A Phase IV Trial

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

Being tested
Abemaciclib + Aromatase Inhibitor, Abemaciclib + Fulvestrant
Keywords
hormone receptor-positive, HER2-negative, locally advanced/metastatic breast cancer, abemaciclib, endocrine therapy, phase IV
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abemaciclib + Aromatase InhibitorDrug

    Also called Verzenios

    Abemaciclib 150 mg orally every 12 hours plus Aromatase Inhibitor ( Anastrozole 1 mg, Letrozole 2.5 mg or exemestane 25 mg orally every 24 hours on Days 1 to 28 of a 28-day cycle)

  • Abemaciclib + FulvestrantDrug

    Also called Verzenios

    Abemaciclib 150 mg orally every 12 hours plus Fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on Day 1 of a 28-day cycle)

Study groups in NCT05362760
Study groupRoleWhat they receive
Abemaciclib + Aromatase-InhibitorExperimentalThe patients will receive Abemaciclib in combination with an Aromatase-Inhibitor (either Anastrozole, Letrozole or exemestane)
Receives: Drug: Abemaciclib + Aromatase Inhibitor
Abemaciclib + FulvestrantExperimentalThe patients will receive Abemaciclib in combination Fulvestrant
Receives: Drug: Abemaciclib + Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS, defined as the time from date of trial registration until progressive disease (PD) or death from any cause, whichever comes first (as defined by RECIST guideline version 1.1). If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

    Measured: Time from date of trial registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary outcomes (10)

  1. Adverse Events

    Adverse Events assessed by investigator (type, frequency, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0)), seriousness)

    Measured: From obtaining informed consent until progressive disease (PD) or up to 30 days after end of trial treatment

  2. Patient-reported side effects

    Additional capture of Patient-Reported side effects on a daily basis via CANKADO PRO-React (patient diary).

    Measured: From first dose of study medication up to 30 days after end of trial treatment

  3. Patient-reported global health status

    Daily self-assessment of global health status using the visual analogue scale (EQ-VAS, based on the EQ-5D questionnaire) via CANKADO. The EQ-VAS scale ranges from 0 (the worst possible health status to 100 (the best possible health status).

    Measured: From first dose of study medication up to 30 days after end of trial treatment

  4. Frequency of hospitalizations

    Frequency of hospitalizations during study treatment

    Measured: Time from date of registration for the trial through study completion (4 years after date of First Patient In)

  5. Patient reported European Organisation for Research and Treatment of Cancer Quality of Life C30 questionaire (EORTC QLQ-C30)

    Patient reported quality of life as assessed with the EORTC QLQ-C30 questionnaire. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At baseline, at 3, 6, 9, 12, 18, 24 months

  6. Patient reported European Organisation for Research and Treatment of Cancer Quality of Life B23 breast cancer module questionaire (EORTC QLQ-BR23)

    Patient reported quality of life as assessed with the EORTC QLQ-BR23 questionnaire. The QLQ-B23 breast cancer module incorporates five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At baseline, at 3, 6, 9, 12, 18, 24 months

  7. Clinical benefit rate (CBR)

    CBR defined as percentage of patients with complete response, partial response or stable disease

    Measured: Time from date of registration for the trial until 24 weeks of study treatment

  8. Overall Survival (OS)

    Overall survival (OS) defined as the time from date of trial registration until date of death due to any cause. If a patient is not known to have died, survival is censored at the date of last contact.

    Measured: Time from date of trial registration until date of death due to any cause, assessed up to 48 months

  9. Objective Response Rate (ORR)

    ORR defined as percentage of patients with complete or partial response as defined by RECIST 1.1

    Measured: Time from date of registration for the trial through study completion (4 years after date of First Patient In)

  10. Number of patients with primary progression

    Number of patients with primary progression, defined as number of patients with disease recurrence within 12 weeks after recruitment.

    Measured: Time from date of registration for the trial until first imaging after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start27 Apr 2022
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-randomized phase 4 clinical trial with two arms (cohorts), i.e. abemaciclib plus aromatase inhibitor or abemaciclib plus fulvestrant, with patient assignment to the arms by physician's choice
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05362760
Sponsor's protocol ID
MINERVA
Other IDs
2021-000287-30
Acronym
MINERVA
Status last verified
May 2025
First submitted
5 Apr 2022
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abemaciclib + Aromatase Inhibitor and Abemaciclib + Fulvestrant in people with Hormone Receptor-positive Metastatic Breast Cancer and HER2-negative Metastatic Breast Cancer, run by Prof. Wolfgang Janni at 54 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalie Uhl (+49 731 500 58652, natalie.uhl@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Time from date of trial registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05362760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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