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    Association details:
    Biomarker:ER positive
    Cancer:HER2 Negative Breast Cancer
    Drug:taselisib (GDC-0032) (PIK3CA inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    ASCO 2018
    Title:

    2018 ASCO: Phase III SANDPIPER Trial Evaluates Taselisib Plus Fulvestrant in Advanced Breast Cancer

    Excerpt:
    ...estrogen receptor–positive, HER2-negative metastatic breast cancer that worsened or recurred despite initial hormone treatment with aromatase inhibitors. Women were randomly assigned to receive fulvestrant and placebo (176 women) or fulvestrant and taselisib (340 women)....The response rate to treatment was more than doubled when taselisib was added (28% vs 11.9%).
    Secondary therapy:
    fulvestrant
    Trial ID:
    SANDPIPER
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

    Excerpt:
    ...- Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen-receptor positive (ER+) breast cancer - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is - Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer - Recurrence or progression during or after aromatase inhibitor - Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Consent to provide tumor tissue (block or a minimum of 20 slides) from the most recent tumor tissue for PIK3CA-mutation testing; a valid cobas® PIK3CA mutation result by central testing is required - Adequate hematologic and end-organ function within 28 days prior to treatment initiation ...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

    Excerpt:
    ...- Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer...
    Trial ID:
    SANDPIPER
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

    Excerpt:
    ...- Estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer...
    Trial ID:
    LORELEI