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    Association details:
    Biomarker:ER positive
    Cancer:HER2 Negative Breast Cancer
    Drug:AiRuiKang (dalpiciclib) (CDK4 inhibitor, CDK6 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

    Excerpt:
    ...A) ER-positive and/or PR-positive are defined as: ≥ 1% of all tumor cells are positively stained (confirmed by investigator review at the site); B) HER2-negative are defined as: 0/1 + by standard immunohistochemistry (IHC); HER2/CEP17 ratio less than 2.0 by ISH or HER2 gene copy number less than 4 (confirmed by investigator review at the site)....
    Trial ID:
    NCT05431504
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    Study to Evaluate the Efficacy and Safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer

    Excerpt:
    ...ER, PR and HER2 detection meet the following conditions to enter the corresponding queue: (1) TNBC cohort: ER, PR, HER2-negative breast cancer patients; (2) HR+/HER2-BC cohort: patients with ER-positive and HER2-negative breast cancer. ...
    Trial ID:
    ChiCTR2100052636
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)

    Excerpt:
    ...- 18F-FES-PET/CT showed at least one ER-positive lesion....
    Trial ID:
    DAWNA-FES
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

    Excerpt:
    ......
    Trial ID:
    NCT05512780
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    A single-arm, multi-center, exploratory clinical study of dalpiciclib combined with standard endocrine therapy in HR-positive, HER2-negative advanced breast cancer

    Excerpt:
    ...Pathological examination confirmed HR+, HER2- invasive breast cancer; estrogen receptor (ER) positive (> 10%), progesterone receptor (PR) positive (> 1%), HER2 negative. ...
    Trial ID:
    ChiCTR2200060315
    Less C2 evidence
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    Front Oncol
    Title:

    Case report: 18F-FES PET/CT predicted treatment responses of second-line and third-line CDK4/6 inhibitors after disease progression on first-line CDK4/6 inhibitor in a HR+/HER2- metastatic breast cancer patient

    Published date:
    12/23/2022
    Excerpt:
    A 70-year-old woman with Parkinson's disease, osteoporosis and cardiovascular co-morbidity was diagnosed with HR+/HER2- breast cancer...Since most of the metastatic lesions were ER-positive, abemaciclib + fulvestrant were chosen as the second-line CDK4/6i treatment and the PFS was 15 months....Since 18F-FES PET/CT revealed that the dominant lesions were still ER-positive, dalpiciclib + exemestane + fulvestrant were prescribed as the third-line CDK4/6i treatment. Currently the patient's disease had been stable for 2 months.
    Secondary therapy:
    fulvestrant + exemestane
    DOI:
    10.3389/fonc.2022.1095779