Clinical Trials /

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

NCT02437318

Description:

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Study Assessing the Efficacy and Safety of <span class="go-doc-concept go-doc-intervention">Alpelisib</span> Plus <span class="go-doc-concept go-doc-intervention">Fulvestrant</span> in Men and Postmenopausal Women With Advanced <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Which Progressed on or After <span class="go-doc-concept go-doc-intervention">Aromatase Inhibitor</span> Treatment.

Title

  • Brief Title: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
  • Official Title: A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
  • Clinical Trial IDs

    NCT ID: NCT02437318

    ORG ID: CBYL719C2301

    NCI ID: 2015-000340-42

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Fulvestrant Faslodex fulvestrant + alpelisib, fulvestrant + placebo
    Alpelisib fulvestrant + alpelisib
    Alpelisib placebo fulvestrant + placebo

    Trial Purpose

    To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free
    survival compared to fulvestrant and placebo in men and postmenopausal women with hormone
    receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment
    with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    fulvestrant + alpelisib Experimental Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) Fulvestrant, Alpelisib
    fulvestrant + placebo Placebo Comparator Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) Fulvestrant, Alpelisib placebo

    Eligibility Criteria

    Inclusion Criteria:

    - If female, patient is postmenopausal

    - Patient has identified PIK3CA status

    - Patients may be:

    - relapsed with documented evidence of progression more than 12 months from
    completion of (neo)adjuvant endocrine therapy with no treatment for metastatic
    disease

    - relapsed with documented evidence of progression on or within 12 months from
    completion of (neo)adjuvant endocrine therapy with no treatment for metastatic
    disease

    - relapsed with documented evidence of progression more than 12 months from
    completion of adjuvant endocrine therapy and then subsequently progressed with
    documented evidence of progression after one line of endocrine therapy for
    metastatic disease

    - newly diagnosed advanced breast cancer, then relapsed with documented evidence
    of progression after one line of endocrine therapy

    - Patient has recurrence or progression of disease during or after AI therapy (i.e.

    letrozole, anastrozole, exemestane).

    - Patient has a histologically and/or cytologically confirmed diagnosis of
    estrogen-receptor positive breast cancer by local laboratory and has HER2 negative
    breast cancer

    - Patient has either measurable disease per RECIST 1.1 criteria OR at least one
    predominantly lytic bone lesion must be present

    - Patient has adequate bone marrow function

    Exclusion Criteria:

    - Patient with symptomatic visceral disease or any disease burden that makes the
    patient ineligible for endocrine therapy per the investigator's best judgment

    - Patient has received prior treatment with chemotherapy (except for neoadjuvant/
    adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment
    with CDK4/6 inhibitors is allowed)

    - Patient with inflammatory breast cancer at screening

    - Patients with Child pugh score B or C

    - Patients with an established diagnosis of diabetes mellitus type I or not controlled
    type II

    - Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more

    - Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy
    completion to starting the study treatment and has stable CNS tumor at time of
    screening and not receiving steroids and/or enzyme inducing ant-epileptic medications
    for brain metastases

    - Patient has participated in a prior investigational study within 30 days prior to
    enrollment or within 5 half-lives of the investigational product, whichever is
    longer.

    Other protocol-defined inclusion/esclusion criteria may apply.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-free survival (PFS)

    Secondary Outcome Measures

    Overall survival (OS)

    Overall response rate (ORR)

    Time ro definitive deterioration of Eastern Cooperative Oncology Group (ECOG) performance status

    Safety and tolerability of alpelisib in combination with fulvestrant

    Time to 10% deterioration in the global health status/Quality of Life (QOL) scale score of the EORTC QLQ-C30

    Plasma concentration-time profile of alpelisib given in combinatio with fulvestrant and appropriate pharmacokinetics (PK) parameters

    PFS based on radiology assessments and using RECIST 1.1 criteria

    Progresion free survival (PFS)

    Clinical benefit rate (CBR)

    Change in the global health status/(QOL) scale score of the EORTC QLQ-C30

    Summary statistics of fulvestrant and alpelisib plasma concentrations

    Trial Keywords

    HR+

    HER2-negative

    advanced breast cancer

    alpelisib

    fulvestrant

    PI3K

    Phase III

    ER+

    PgR+

    men

    postmenopausal

    aromatase inhibitor

    neoplasms