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    Association details:
    Biomarker:HER-2 negative
    Cancer:HER2 Negative Breast Cancer
    Drug:Kisqali (ribociclib) (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...First-Line therapy, Aromatase inhibitor + CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) (category 1)....Preferred Regimens...Second and subsequent line therapy...Fulvestrant + CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) if CDK4/6 inhibitor not previously used (category 1)
    Secondary therapy:
    Aromatase inhibitor; fulvestrant
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    N Engl J Med
    Title:

    Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer

    Published date:
    07/25/2019
    Excerpt:
    ...assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen)....The survival benefit seen in the subgroup of 495 patients who received an aromatase inhibitor was consistent with that in the overall intention-to-treat population (hazard ratio for death, 0.70; 95% CI, 0.50 to 0.98). The percentage of patients who received subsequent antineoplastic therapy was balanced between the groups (68.9% in the ribociclib group and 73.2% in the placebo group). The time from randomization to disease progression during receipt of second-line therapy or to death was also longer in the ribociclib group than in the placebo group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.55 to 0.87).
    Secondary therapy:
    Aromatase inhibitor
    DOI:
    10.1056/NEJMoa1903765
    Trial ID:
    MONALEESA-7
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts

    Excerpt:
    ...- Documented HER2-negative tumor based on local testing on most recent tumor biopsy: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined by current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines....
    Trial ID:
    LEANORA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer

    Excerpt:
    ...- Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer...
    Trial ID:
    EarLEE-1
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer

    Excerpt:
    ...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer, HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+, and metastatic breast cancer...
    Trial ID:
    NCT03477396
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

    Excerpt:
    ...Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+....
    Trial ID:
    CAPTOR-BC
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Combined treatment (hormone and biological therapy) for patients with advanced breast cancer with hormone (HR) positive and HER2 negative receptors Trattamento combinato (terapia ormonale + biologica) per i pazienti con carcinoma mammario avanzato con recettori ormonali (HR) positivi ed HER2 negativo

    Excerpt:
    ...Patient has a HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. ...
    Trial ID:
    2018-002514-12
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

    Excerpt:
    ...- Participants must have biopsy proven localized ER+ (≥ 10%), HER2 negative, invasive breast cancer, with pathological stage (including post-neoadjuvant therapy) T1c-T4c, any N, M0, by AJCC 7th edition staging....
    Trial ID:
    LEADER
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer

    Excerpt:
    ...HER2-negative breast cancer....
    Trial ID:
    NCT06075758
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.

    Excerpt:
    ...- Patient has HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+....
    Trial ID:
    NCT03671330
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer

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

    Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

    Excerpt:
    ...- Participant has HER2-negative breast cancer...
    Trial ID:
    ADJUVANT WIDER
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

    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:
    AMALEE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Ribociclib and Bicalutamide in AR+ TNBC

    Excerpt:
    ......
    Trial ID:
    NCT03090165
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

    Excerpt:
    ...- Patient has HER2-negative breast cancer...
    Trial ID:
    MONALEESA-7
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

    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:
    RaPhLRR
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

    Excerpt:
    ...Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer....
    Trial ID:
    MONALEESA-3
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

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

    Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

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

    Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

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

    Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

    Excerpt:
    ...- Histologically confirmed unresectable, locally advanced or metastatic invasive breast cancer with hormone receptor positive/HER2 negative...
    Trial ID:
    NCT05816655
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

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

    FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer

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

    Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

    Excerpt:
    ...Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1 + or 2 + If IHC is 2 +, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample....
    Trial ID:
    RIGHT Choice
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

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

    Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

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

    Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

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

    Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole

    Excerpt:
    ...in ≥ 50% of cancer cells) and HER-2 negative, luminal A/B breast cancer...
    Trial ID:
    NEOLETRIB
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Managed Access Program to Provide Access to Ribociclib, for Locally Advanced or Metastatic Cancer Resistant or Refractory to Available Treatment Options and Candidate for Therapy With a CDK Inhibitor

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

    Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

    Excerpt:
    ...- Invasive breast cancer must be HER2 negative....
    Trial ID:
    FELINE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer

    Excerpt:
    ...- Human Epidermal growth factor Receptor 2 Negative (HER2-) breast cancer defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+....
    Trial ID:
    NCT02586675
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

    Excerpt:
    ...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory....
    Trial ID:
    RIBECCA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

    Excerpt:
    ...- Histologically or cytologically confirmed diagnosis of HR-positive (ER+ ≥10%), HER2-negative advanced stage breast cancer...
    Trial ID:
    SAKK 21/18
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

    Excerpt:
    ...- Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer...
    Trial ID:
    TRINITI-1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.

    Excerpt:
    ...ER-positive and/or PgR-positive and HER2-negative tumor by ASCO/CAP guidelines assessed locally....
    Trial ID:
    CORALLEEN
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer

    Excerpt:
    ...- Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer...
    Trial ID:
    EarLEE-2
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    CORALLEEN: A Phase 2 Clinical Trial of multi-agent Chemotherapy or letrozole plus Ribociclib (LEE001) as neoadjuvant treatment for postmenopausal patients with Luminal B/HER2-negative breast cancer. CORALLEEN: Ensayo clínico de fase 2 de poliquimioterapia o letrozol más ribociclib (LEE001) como tratamiento neoadyuvante en pacientes posmenopáusicas con cáncer de mama de tipo luminal B y HER2 negativo.

    Excerpt:
    ...ER-positive and/or PgR-positive and HER2-negative tumor by ASCO/CAP guidelines assessed locally.9. ...
    Trial ID:
    2016-003098-17
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2 negative advanced breast cancer on first-line treatment with ribociclib and letrozole Studio sulle caratteristiche molecolari di donne in post menopausa con carcinoma mammario avanzato positivo per il recettore ormonale (HR+) HER2 negativo, in trattamento di prima linea con ribociclib e letrozolo

    Excerpt:
    ......
    Trial ID:
    2017-004176-62
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Ribociclib combined with hormone therapy versus chemotherapy as first line treatment for advanced breast cancer with visceral disease. A multicenter, randomized phase III trial.

    Excerpt:
    ...Histologically or cytologically confirmed diagnosis of hormone receptor positive (ER+ ≥10%), HER2 negative, metastatic breast cancer.2. ...
    Trial ID:
    2018-003648-22
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Anti-hormonal Therapie with or without Ribociclib in HR-positive / HER2-negative metastatic breast cancer. Antihormontherapie mit oder ohne Ribociclib bei Hormonrezeptor-positivem / HER2-negativem metastasiertem Brustkrebs.

    Excerpt:
    ...Histologisch gesicherter HER2-negativer, Hormonrezeptor-positiver lokal fortgeschrittener oder metastasierter Brustkrebs. ...
    Trial ID:
    2017-003667-35
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    DetectIV - Treatment of patients with advanced metastatic breast cancer and circulating blood cells devoid of Her2/neu. DetectIV - Behandlung von Patientinnen mit metastierendem Brustkrebs, bei denen die im zirkulierenden Tumorzellen kein Her2/neu aufweisen.

    Excerpt:
    ...HER2-negativity is defined as (i.e.: immunohistochemistry (IHC) score 0-1+ or 2+ and fluorescent in situ hybridization (FISH) negative or just FISH negative, whichever was performed) in all tissue samples.3. ...
    Trial ID:
    2013-001269-18
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer

    Excerpt:
    ...- ER and/or PR-positive (≥ 1% positivity as determined by local pathology laboratory), HER2-negative breast cancer with > 3 lymph nodes involved on sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) OR have between 1-3 lymph nodes involved AND have T3 disease OR have between 1-3 lymph nodes involved and grade 3 breast cancer....
    Trial ID:
    NCT05996107
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    BMC Cancer
    Title:

    Proton pump inhibitors may reduce the efficacy of ribociclib and palbociclib in metastatic breast cancer patients based on an observational study

    Published date:
    05/07/2022
    Excerpt:
    We enrolled hormone receptor-positive, HER2-negative mBC patients treated with endocrine treatment (letrozole or fulvestrant) combined palbociclib or ribociclib alone or with PPI accompanying our observational study....In the palbociclib group, the PFS of the patients using PPIs was shorter than the PFS of the patients not using (13.04 months vs. unreachable, p < 0.001)....In the ribociclib group, the PFS of the patients using PPIs was shorter than the PFS of the patients not using (12.64 months vs. unreachable, p = 0.003)....Our study demonstrated that concomitant usage of PPIs was associated with shorter PFS in mBC treated with both ribociclib and especially palbociclib.
    Secondary therapy:
    Proton pump inhibitor + fulvestrant; Proton pump inhibitor + letrozole
    DOI:
    10.1186/s12885-022-09624-y