Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Michelle Melisko

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 Breast Neoplasms Estradiol Aromatase Inhibitors fulvestrant + alpelisib

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

  • University of California San Francisco
    San Francisco California 94115 United States
  • St. Helena Martin ONeil Cancer Center, Napa Valley SC
    Helena California 94574 United States

Lead Scientist

  • Michelle Melisko
    Dr. Michelle E. Melisko is a cancer specialist with expertise in breast cancer treatment and research. She is interested in testing new chemotherapy combinations, biological therapies and immunotherapies for breast cancer, with a particular focus on treatment of cancer that has spread to the brain.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02437318
Phase
Phase 3
Study Type
Interventional
Last Updated