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    Association details:
    Biomarker:HER-2 negative
    Cancer:HER2 Negative Breast Cancer
    Drug:Trodelvy (sacituzumab govitecan-hziy) (Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

    Excerpt:
    ...Centrally confirmed HER2-negative (IHC score 0-1 or FISH negative according to ASCO/CAP guideline) and either...
    Trial ID:
    SASCIA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

    Excerpt:
    ...- Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed...
    Trial ID:
    EVER-132-002
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

    Excerpt:
    ......
    Trial ID:
    ASCENT-07
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors

    Excerpt:
    ...- Phase 2 hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2- mBC)...
    Trial ID:
    ASCENT-J02
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

    Excerpt:
    ...- Clinical stage IV (metastatic) estrogen receptor (ER), PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis and that meets the following criteria:...
    Trial ID:
    NCT05770531
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Sacituzumab Govitecan In TNBC

    Excerpt:
    ...- Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative (HER2-), invasive breast cancer....
    Trial ID:
    NeoSTAR
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

    Excerpt:
    ...- Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed....
    Trial ID:
    TROPiCS-02
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

    Excerpt:
    ...- Participants must have histologically confirmed HER2-negative (per 2018 American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] joint guideline) invasive breast cancer that has metastasized to the brain....
    Trial ID:
    NCT04647916
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO Asia 2022
    Title:

    22MO - Efficacy and safety of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer (mTNBC) by baseline HER2 expression level: Subgroup analysis from a phase IIb trial

    Published date:
    11/28/2022
    Excerpt:
    According to Independent Review Committee assessment, objective response rate was 41.9% (95% confidence interval [CI] 27.01-57.87) in HER2-neg group and 35.1% (95% CI 20.21-52.54) in HER2-low group, and clinical benefit rate was 46.5% (95% CI 31.18-62.35) and 40.5% (95% CI 24.75-57.90), respectively. Median progression free survival was 6.9 months (95% CI 4.21-NA) in HER2-neg and 5.5 months (95% CI 2.83-NA) in HER2-low....SG showed comparable anti-tumor activity in both HER2-neg and HER2-low subgroups of later line Chinese mTNBC pts.
    Trial ID:
    EVER-132-001