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    Association details:
    Biomarker:HR positive
    Cancer:Hormone Receptor Positive Breast Cancer
    Drug:Piqray (alpelisib) (PIK3CA inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    Impact of time of alpelisib administration, concomitant fasting and low carbohydrate diet on alpelisib toxicity and efficacy; a pilot randomized controlled phase IIb trial - ITACA UTJECAJ VREMENA PRIMJENE ALPELISIBA, ISTOVREMENOG POSTA I PREHRANE S NISKIM UDJELOM UGLJIKOHIDRATA NA TOKSIČNOST I UČINKOVITOST ALPELISIBA; RANDOMIZIRANO I KONTROLIRANO PILOT ISPITIVANJE

    Excerpt:
    ...Patient is an adult male or female (≥ 18 years of age) with advanced (loco regionally recurrent not amenable to curative therapy or metastatic) hormone receptor-positive, HER2-negative breast cancer2. ...
    Trial ID:
    2021-000845-42
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

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

    Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

    Excerpt:
    ...- Postmenopausal females and males ≥ 18 years old with confirmed HR-positive, HER2-negative advanced or metastatic breast cancer....
    Trial ID:
    ALPINIST
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

    Excerpt:
    ...Histologically confirmed metastatic HR-positive, HER2-negative breast cancer....
    Trial ID:
    NCT05966584
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Post Marketing Surveillance on Piqray in Korea

    Excerpt:
    ...Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer....
    Trial ID:
    NCT05293470
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

    Excerpt:
    ...Must meet standard clinical criteria for utilization of alpelisib including hormone-receptor positive/HER2 negative cancer with the presence of a PIK3CA mutation....
    Trial ID:
    NCT06083038
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world

    Excerpt:
    ...Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry [IHC], for borderline2+ Fluorescence In Situ Hybridization [FISH]) 4....
    Trial ID:
    SPEAR
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer

    Excerpt:
    ...Hormone receptor positive (HR+) and...
    Trial ID:
    SAFIR PI3K
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    A phase II randomized trial comparing alpelisib and fulvestrant versus chemotherapy as maintenance therapy in patients with PIK3CA mutated advanced breast cancer

    Excerpt:
    ...Hormone receptor positive (HR+) and no Her2 over-expression, according to local assessment. ...
    Trial ID:
    2017-000154-19
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Front Oncol
    Title:

    Real World Outcomes with Alpelisib in Metastatic Hormone Receptor-Positive Breast Cancer Patients: A Single Institution Experience

    Published date:
    10/10/2022
    Excerpt:
    PIK3CA-mutated breast cancer treated with alpelisib...Clinical responses were determined using RECIST v1.1. 3/27 (11.11%) patients discontinued therapy before response assessment due to grade 3 AEs. Overall response rate was 12.5% (3/24), with all partial responses (PR). The median duration of response was 5.77 months (range: 5.54, 8.98). 14/27 (51.9%) of patients required dose interruption/reduction.
    DOI:
    10.3389/fonc.2022.1012391