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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

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

Keywords

Breast Cancer HR+ HER2-negative advanced breast cancer alpelisib fulvestrant PI3K Phase III ER+ PgR+ men postmenopausal aromatase inhibitor neoplasms Estradiol Aromatase Inhibitors

Eligibility

You can join if…

Open to people ages 18 years and up

  • If female, patient is postmenopausal
  • Patient has identified PIK3CA status
  • Patients may be:
  • relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy 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 (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
  • newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only 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

You CAN'T join if...

  • 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
  • Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
  • Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease

    Other protocol-defined inclusion/esclusion criteria may apply.

Locations

  • St. Helena Martin ONeil Cancer Center, Napa Valley SC accepting new patients
    Helena, California, 94574, USA
  • Valley Medical Oncology Consultants accepting new patients
    Pleasanton, California, 94588, USA
  • Mercy Dignity Health of Greater Sacramento withdrawn
    Sacramento, California, 95816, USA
  • California Pacific Medical Center SC-2 accepting new patients
    San Francisco, California, 94120, USA
  • Beverly Hills Cancer Center accepting new patients
    Beverly HIlls, California, 90211, USA
  • City of Hope National Medical Center accepting new patients
    Duarte, California, 91010, USA
  • Compassionate Cancer Care Medical Group CCCMG accepting new patients
    Fountain Valley, California, 92708, USA
  • Scripps Clinic SC accepting new patients
    La Jolla, California, 92037, USA
  • University of California San Diego - Moores Cancer Center Onc Dept. accepting new patients
    La Jolla, California, 92093, USA
  • White Memorial Medical Group, Inc. SC accepting new patients
    Los Angeles, California, 90033, USA
  • Kaiser Permanente - California Southern accepting new patients
    San Diego, California, 92120, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02437318
Phase
Phase 3
Lead Scientist
Michelle Melisko
Study Type
Interventional
Last Updated
October 2016
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