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Ipatasertib/Paclitaxel as a Tx for Breast Cancer (IPATunity130)

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

  • Clinical Trial Information

    Trial Contact: Jobson, Gillian S; Morales, Leticia

    Trial Phone: 321.841.2285 ; 321.841.9623

  • IRB No: 18.148.11

    Protocol Abbrev: CO40016/IPATunity130

    Principal Investigator: Ana Elisa Cuesta Fernandez, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CO40016

    Treatment: Ipatasertib in Combination With Paclitaxel (Placebo controlled)

    Therapies Involved: Oncology: 1st line

    ClinicalTrials.gov ID: NCT03337724

  • Objective

    This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy

  • Key Eligibility

    Inclusion Criteria:
    •   Women or men aged =>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
    •   Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy)
    •   HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following: patient has recurrent disease <=5 years of being on adjuvant endocrine therapy or if patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy.
    •   Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status

    Exclusion Criteria:
    •   Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation
    •   Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a 12 month disease-free interval)
    •   History of or known presence of brain or spinal cord metastases
    •   Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
    •   Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)
    •   History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills