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    Association details:
    Biomarker:PIK3CA mutation
    Cancer:Breast Cancer
    Drug:Piqray (alpelisib) (PI3Kα inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Biomed Res Int
    Title:

    Which Is the Most Appropriate PI3K Inhibitor for Breast Cancer Patients with or without PIK3CA Status Mutant? A Systematic Review and Network Meta-Analysis

    Published date:
    12/03/2020
    Excerpt:
    Nine eligible RCTs involving 3872 BC patients and four PI3K inhibitor therapy arms (i.e., alpelisib, buparlisib, pictilisib, and taselisib) were included....The PI3K inhibitors alpelisib and buparlisib appear to have superior efficacy and safety therapeutic choices for patients with BC, especially in PIK3CA-mutated patients.
    DOI:
    10.1155/2020/7451576
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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 has documented evidence of a mutation in the PIK3CA gene as determined in tumor tissue or plasma by a local laboratory.3. ...
    Trial ID:
    2021-000845-42
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A Phase II exploratory, open-label, single arm study of BYL719 monotherapy, a selective PI3K alpha inhibitor, in adult patients with advanced breast cancer progressing after first line therapy

    Excerpt:
    ...*Patients are defined as “PI3K abnormal” if they have documented gene mutation in AKT1,2,3,ALK, EGFR, ERBB2,3,4, HRAS, INPP4B, KRAS, NRAS, PTEN, PIK3CA, PIK3R1, PIK3R3, PTEN or gene amplification in EGFR, PIK3CA, PIK3R1 or loss in PTEN and INPP4B as per a next generation targeted gene sequencing panel...
    Trial ID:
    ACTRN12615000850572
    More C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2023
    Title:

    Efficacy and Safety of Alpelisib in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor: An Open-label, Multi-centre, Prospective, Single Arm Clinical Trial

    Published date:
    12/02/2023
    Excerpt:
    Our trial demonstrates activity of alpelisib in patients with PIK3CA mutated advanced breast cancer in later lines of treatment after treatment with CDK4/6 inhibitors with a clinical benefit rate of 26.3%.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Res Sq
    Title:

    Phase Ib and pharmacokinetics study of alpelisib, a PIK3CA inhibitor, and capecitabine in patients with advanced solid tumors

    Published date:
    07/18/2023
    Excerpt:
    Patients with 6 colorectal cancer (three PIK3CA mutation) and 6 breast cancer (all PIK3CA mutation) were enrolled. The first three patients in dose level 0 (alpelisib 200mg, capecitabine 1,000 mg/m2)...Antitumor activity was observed in patients with PIK3CA mutant breast cancer (3 partial response and 3 stable disease)....This combination is generally tolerated, and shows antitumor activity in patients with PIK3CA mutant advanced cancers.
    Secondary therapy:
    capecitabine
    DOI:
    https://doi.org/10.21203/rs.3.rs-3174557/v1
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2021
    Title:

    Likelihood of benefit from large panel genetic profiling in a community hospital system

    Published date:
    05/19/2021
    Excerpt:
    With the addition of targeted agents, 4 patients (3.9%) displayed clinical benefit. Two of these patients had gastric and endometrial carcinoma with high TMB and were placed on immunotherapy. They experienced 638 and 465 days, respectively, of stable disease with partial response. Another breast cancer patient had a PIK3CA mutation with PFS of 131 days on alpelisib.
    DOI:
    10.1200/JCO.2021.39.15_suppl.e15025
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Drugs Today (Barc)
    Title:

    Alpelisib to treat breast cancer

    Published date:
    06/01/2020
    Excerpt:
    The combination of alpelisib with fulvestrant or an aromatase inhibitor such as letrozole is safe and effective with reversible toxicities. Although clinical activity has been observed independently of PIK3CA mutation status, clinical improvement has been mostly seen in a higher proportion of patients with PIK3CA-mutated tumors. In this review I share current data on alpelisib in breast cancer treatment.
    Secondary therapy:
    fulvestrant; letrozole
    DOI:
    10.1358/dot.2020.56.6.3137526
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    AACR 2023
    Title:

    3447 - NOS inhibition reverses epithelial-to-mesenchymal transition and synergizes with alpelisib in metaplastic breast cancer

    Published date:
    03/15/2023
    Excerpt:
    L-NMMA was synergistic with alpelisib in MpBC cell lines with PIK3CA/PIK3R1 mutations…. In vivo evaluation using MpBC PDX tumors found that L-NMMA augmented the efficacy of alpelisib in reducing tumor volume in PIK3CA-mutated MpBC PDX models….We find that combining L-NMMA and alpelisib is a novel therapeutic strategy to treat MpBC...
    Secondary therapy:
    L-NMMA
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    SABCS 2022
    Title:

    NOS inhibition reverses epithelial-to-mesenchymal transition and synergizes with alpelisib in metaplastic breast cancer

    Published date:
    11/22/2022
    Excerpt:
    Combining L-NMMA with alpelisib was synergistic in MpBC cell lines harboring PIK3CA/PIK3R1 mutations (CI< 1)….In vivo evaluation using MpBC PDX tumors found that L-NMMA significantly augmented the efficacy of alpelisib in reducing tumor volume in PIK3CA-mutated MpBC PDX models.
    Secondary therapy:
    L-NMMA