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    Association details:
    Biomarker:HER-2 negative
    Cancer:HER2 Negative Breast Cancer
    Drug:Verzenio (abemaciclib) (CDK4 inhibitor, CDK6 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    HER2-Negative and postmenopausal or premenopausal receiving ovarian ablation or suppression: Preferred Regimens: Second and subsequent line therapy...Fulvestrant + CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) if CDK4/6 inhibitor not previously used (category 1)....Preferred Regimens: First-Line therapy, Aromatase inhibitor + CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) (category 1).
    Secondary therapy:
    fulvestrant; Aromatase inhibitor
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    _ Étude comparant deux traitements standards en situation métastatique initiale chez les patientes atteintes d’un cancer du sein ER positif - HER2 négatif avec des métastases viscérales : chimiothérapie et hormonothérapie associée à l’abémaciclib

    Excerpt:
    ...HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish negative.9. ...
    Trial ID:
    2019-000260-14
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A study of abemaciclib combined with endocrine therapy (letrozole or fulvestrant)with or without a short course of chemotherapy with paclitaxel in patients withunresectable locally advanced or metastatic breast cancer with aggressive disease criteria. Uno studio di abemaciclib combinato con la terapia endocrina (letrozolo o fulvestrante) con o senza un breve ciclo di chemioterapia con paclitaxel in pazienti con tumore al seno non resecabile localmente avanzato o metastatico con criteri di malattia aggressivi.

    Excerpt:
    ...1.Signed ICF prior participation in any study-related activities2.Male/female patients#18y time signed ICF3.ECOG performance status of 0/14.Life expectancy at least 24weeks5.Pre-menopausal/peri-menopausal women who are being treated w/ a luteinizing hormone-releasing hormone analog for at least 28d prior to study entry(if shorter,post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH]must be confirmed analytically)/post-menopausal women as defined by any of following criteria:a.Documented bilateral oophorectomyb.Age#60yc.Age1.5×ULN8.Histologically confirmed ERs- &/or PGR(PgR)-positive & HER2-negative breast cancer based on local testing on the most recent analyzed biopsy9.Measurable disease as per RECIST v1.1 w/ at least 1site of disease amenable to biopsy.Patients w/ bone lesions as only sites of metastatic disease are not eligible,except for patients w/ identifiable soft tissue components,evaluable by cross sectional imaging techniques such as CT /MRI,and that meet the definition of measurability according RECIST v1.110.Willingness & ability to provide tumor biopsy from metastatic site /primary breast tumor at time of inclusion to perform exploratory studies If not feasible,patient eligibility should be evaluated by Sponsor11.Willingness to provide blood samples for exploratory studies atbaseline,after 2w treatment & at progression (or treatment termination prior to start alternative anti-cancer therapy)12.Patients relapsing on a CDK 4/6 inhibitor-based regimen in the neoadjuvant /adjuvant setting will be suitable for the study if disease progression is confirmed after at least 12m following CDK4/6 treatment completion13.No prior systemic therapy for unresectable locally advanced /metastatic disease14.Radiation therapy for metastatic disease permitted,patient must have fully recovered from the acute effects & at least 14d must have elapsed b/w the last dose & randomization15.Resolution of all acute toxic effects of prior anti-cancer therapy toGrade#1 as determined by NCI-CTCAE v5.0 (except for Grade#2 neuropathy,alopecia,toxicities not considered a safety risk at investigator's discretion) within at least 14d prior to D116.Adequate hematologic & organ function within 14d before the 1st treatment on D1C1,defined by:a.WBC>3.0×109/L;ANC#1.5×109/L(w/t GCSF support within 2w prior D1C1)Platelet count#100×109/L(w/t transfusion within 2w prior D1C1);Hemoglobin>9.0g/dL (w/t transfusion within 2w prior D1C1)b.Serum albumin#3g/dL,Total bilirubin#1.5×ULN(#2×ULN in Gilbert’s disease)AST/ALT#3.0×ULN(in liver metastases #5×ULN)ALP#2.5×ULN(in liver and/or bone metastases #5×ULN)c.Serum creatinine post-menopausa:a.Ovariectomia bilaterale documentatab.Età=60aac.Età1.5×ULN8.Carcinoma confermato istologicamente con test locali sulla +recente biopsia analizzata con ERs e/o PGR(con=1%cellule colorate+ secondo linee guida NCC e ASCO) HER2- (0/1+ x immunoistochimica o 2+ a - x test ISH)9.Malattia misurabile x RECIST v 1.1 con almeno 1sito malattia suscettibile biopsia.No pazienti con lesioni ossee come unici siti di malattia metastatica,- pazienti con componenti identificabili tessuti molli,valutabili mediante TC/MRI e conformi misurabilità x RECIST v1.110.Disponibilità e capacità fornire biopsia tumorale da sito metastatico/tumore mammario primario nell'inclusione x studi esplorativi.altrimenti,ammissibilità paziente valutata da personale qualificato11.Disponibilità x campioni di sangue x studi esplorativi al basale,dopo 2sett trattamento e progressione(o al termine del trattamento in studio prima di iniziare una terapia antitumorale alternativa)12.I pazienti recidivanti in regime basato sull’inibitore CDK4/6 in ambito neoadiuvante o adiuvante saranno ammessi lo studio se la progressione della malattia è confermata dopo almeno 12mm dal completamento del trattamento con CDK4/613.Nessuna precedente terapia sistemica x malattia localmente avanzata o metastatica non resecabile14.È consentita radioterapia x malattia metastatica,il paziente deve essersi completamente ripreso dagli effetti acuti e devono essere trascorsi almeno 14gg tra ultima dose e randomizzazione15.Risoluzione fino grado=1 almeno 14gg prima del G1 di tutti gli effetti tossici acuti della precedente terapia antitumorale determinata mediante NCI-CTCAE v.5.0(eccez. ...
    Trial ID:
    2020-001648-24
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Clinical trial to compare efficacy and safety of standard chemotherapy versus letrozole plus abemaciclib, chosen randomly, as neoadjuvant therapy (deliver before breast cancer surgery), with positive Hormone Receptors (female hormones) and negative HER2 (protein involved in cell division that is located in the surface of many cells), intermediate/high risk breast cancer Estudio clínico para comparar eficacia y seguridad de la quimioterapia estándar frente a letrozol más abemaciclib, asignado al azar, como terapia neoadyuvante (administrada antes de la cirugía del tumor de mama), en pacientes con cáncer de mama con receptores hormonales (hormonas femeninas) positivos y HER2 (proteína involucrada en la división celular que se encuentra en la superficie de numerosas células) negativo, de riesgo alto/intermedio

    Excerpt:
    ...1.Written informed consent prior to any specific study procedures2.Women > or = 18 years of age3.Documentation of histologically confirmed primary invasive adenocarcinoma of the breast4.Availability of a primary tumor tissue sample obtained during the diagnostic process before treatment for the central assessment of Ki67 index5.Documentation of HR positive and HER2 negative BC based on local laboratory determination.a.HR positive is defined as more than or equal to 10% positive cells by IHC for ER and/or progesterone receptor (PgR)b.HER2 negative tumor is determined according to recommendations of ASCO/CAP 2018 guidelines6.Intermediate and high risk patients based on Ki67 index value (> or = 20%) determined at a central laboratory7.Patients should be in the following clinical stages of disease according to the 8th edition of the TNM Classification of Breast Cancer by the UICC (Union for International Cancer Control): T2 (> 2cm) – T3, T4b, N0 – N2, M0 (stages IIA, IIB, IIIA or IIIB). ...
    Trial ID:
    2019-002123-15
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

    Excerpt:
    ......
    Trial ID:
    MONARCH 2
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

    Excerpt:
    ......
    Trial ID:
    monarchE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

    Excerpt:
    ......
    Trial ID:
    postMONARCH
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib

    Excerpt:
    ...- Clinical stage operable stage I, II, or III invasive mammary carcinoma, which is estrogen receptor or progesterone receptor positive by immunohistochemistry and HER2 negative by Herceptest (0 or 1+) or...
    Trial ID:
    NCT04614194
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer

    Excerpt:
    ......
    Trial ID:
    NCT03130439
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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

    Excerpt:
    ......
    Trial ID:
    MINERVA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

    Excerpt:
    ......
    Trial ID:
    nextMONARCH 1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

    Excerpt:
    ......
    Trial ID:
    MONARCH plus
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

    Excerpt:
    ......
    Trial ID:
    NCT03703466
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer

    Excerpt:
    ......
    Trial ID:
    TRADE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

    Excerpt:
    ...- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer...
    Trial ID:
    MONARCH 3
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

    Excerpt:
    ...- Qualifying risk status, at diagnosis utilizing receptor testing by ASCO/CAP guidelines, meting at least one of the following: (i) Histologically positive axillary lymph nodes, regardless of receptors (ii) Primary tumor that is ER/PR/Her2 negative: estrogen receptor (ER) /= 25 per the Genomic Health Oncotype DX breast cancer test and/or high risk MammaPrint (iv) Evidence of residual disease in the breast on pathologic assessment after neoadjuvant chemotherapy...
    Trial ID:
    ABBY
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

    Excerpt:
    ...Histologically confirmed ER-positive, HER2-negative metastatic breast cancer....
    Trial ID:
    NCT05305924
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

    Excerpt:
    ...Age mprehensive Cancer Network and American Society of Clinical Oncology guidelines) and HER2 negative (0 to 1+ by immunohistochemistry or 2+ and negative by in situ hybridization test) breast cancer based on local testing on the most recent analyzed biopsy....
    Trial ID:
    ABIGAIL
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC

    Excerpt:
    ...Patient has HER2-negative breast cancer defined as...
    Trial ID:
    ADAPTlate
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

    Excerpt:
    ......
    Trial ID:
    NCT05095207
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer

    Excerpt:
    ...- HER2 negative status is determined by:...
    Trial ID:
    NCT04352777
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases

    Excerpt:
    ......
    Trial ID:
    MCC-20899
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer

    Excerpt:
    ...HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish negative....
    Trial ID:
    AMBRE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.

    Excerpt:
    ...- HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines...
    Trial ID:
    NCT04305834
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

    Excerpt:
    ...Tumour HER2 negative or HER2 status unknown....
    Trial ID:
    POETIC-A
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients

    Excerpt:
    ...Histologically proven diagnosed estrogen receptor positive, HER2 negative metastatic breast cancer...
    Trial ID:
    Abemacare
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

    Excerpt:
    ...- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer...
    Trial ID:
    NCT04707196
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients

    Excerpt:
    ...Documentation of Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative Breast Cancer (BC) based on local laboratory determination....
    Trial ID:
    CARABELA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)

    Excerpt:
    ...Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+....
    Trial ID:
    HERMIONE-7
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.

    Excerpt:
    ...Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+....
    Trial ID:
    ATLANT
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Real-world Data in Patients With Breast Cancer Treated With Abemaciclib

    Excerpt:
    ...- Histologically confirmed HR-positive, HER2-negative breast cancer...
    Trial ID:
    NCT04985058
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

    Excerpt:
    ......
    Trial ID:
    NCT04031885
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Implementing Patients´ Competence in Oral Breast Cancer Therapy

    Excerpt:
    ......
    Trial ID:
    IMPACT
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread

    Excerpt:
    ...- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer....
    Trial ID:
    MONARCH 1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

    Excerpt:
    ......
    Trial ID:
    proMONARCH
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

    Excerpt:
    ...- Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer....
    Trial ID:
    NCT02792725
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Abemaciclib as neoadjuvant, chemo-free treatment for patients with breast cancer with low expression of estrogen receptors. A clinical and biological study. Abemaciclib come trattamento prechirurgico, non chemioterapico, di pazienti affette da carcinoma mammario con bassa espressione del recettore per gli estrogeni. Studio clinico-biologico.

    Excerpt:
    ...• Adult patients, male or female aged = o > 18 years at the time of informed consent.• T1cN0 - T3N0 infiltrating breast cancer without evidence of metastatic disease, not previously treated.• Histologically confirmed diagnosis of infiltrating breast cancer with low estrogen receptor positivity (1-10%).• HER2-negative breast cancer defined with a negative in situ hybridization test (ISH) or an immunohistochemical status (IHC) of 0, 1+, or 2+. ...
    Trial ID:
    2020-005792-12