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.

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.

Key facts

Study ID

NCT02437318

Run by

Novartis Pharmaceuticals

People needed

572

Starts

2015-07-23

Expected to finish

2023-06-09

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• If female, the patient was postmenopausal.
• The patient had identified PIK3CA status.
• Patients could 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 with advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy.
• The patient had recurrence or progression of the disease during or after AI therapy (i.e., letrozole, anastrozole, exemestane).
• The patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by a local laboratory and had HER2 negative breast cancer.
• The patient had either measurable disease per RECIST 1.1 criteria or at least one predominantly lytic bone lesion present.
• The patient had adequate bone marrow function.

You may not qualify if…

• The patient had symptomatic visceral disease or any disease burden that made the patient ineligible for endocrine therapy per the investigator's best judgment.
• The patient had received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, any PI3K, mTOR, or AKT inhibitor (pre-treatment with CDK4/6 inhibitors was allowed).
• The patient had inflammatory breast cancer at screening.
• Patients had Child pugh score B or C.
• Patients had an established diagnosis of diabetes mellitus type I or uncontrolled type II.
• The patient had Eastern Cooperative Oncology Group (ECOG) performance status 2 or more.
• The patient had CNS involvement unless he/she was at least 4 weeks from prior therapy completion to starting the study treatment and had a stable CNS tumor at the time of screening and was not receiving steroids and/or enzyme-inducing antiepileptic medications for brain metastases.
• The patient had participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever was longer.
• The patient had a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis.
• The patient relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease.

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• Scripps Green Hospital — La Jolla, California, United States
• Kaiser Permanent Southern Californi — San Diego, California, United States
• UCSF — San Francisco, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists-North — St. Petersburg, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Edward Cancer Center — Naperville, Illinois, United States
• Fort Wayne Medical Oncology Hematology Inc — Fort Wayne, Indiana, United States
• St Francis Health Comprehensive Cancer Center — Topeka, Kansas, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Detroit Clinical Research Center — Owosso, Michigan, United States
• St Lukes Cancer Institute — Kansas City, Missouri, United States
• St Vincent Frontier Cancer Center — Billings, Montana, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• University Hospitals of Cleveland Seidman Cancer Center — Cleveland, Ohio, United States
• Good Samaritan Regional Medical Center — Corvallis, Oregon, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Ironwood Cancer and Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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