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.



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:July 23, 2015
End Date:April 15, 2020

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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

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.


Inclusion Criteria:

- 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

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

- 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.
We found this trial at
56
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Baton Rouge, Louisiana 70808
Principal Investigator: Gerald Miletello
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Albany, New York 12206
Principal Investigator: Karen Tedesco
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Baltimore, Maryland 21202
Principal Investigator: David Andrew Riseberg
Phone: +1 410 332 1200
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Berazategui, Buenos Aires
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Beverly Hills, California 90211
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Billings, Montana 59102
Principal Investigator: Patrick Cobb
Phone: 406-238-6962
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55 Fruit Street
Boston, Massachusetts 02114
Principal Investigator: Dejan Juric
Phone: 617-724-0878
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Camp Hill, Pennsylvania 17011
Principal Investigator: Robert Gordon
Phone: 717-761-8740
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2560 West Chandler Boulevard
Chandler, Arizona 85224
Principal Investigator: Mikhail I. Shtivelband
Phone: 480-855-2227
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Charleston, South Carolina 29414
Principal Investigator: Gene Saylors
Phone: 843-577-6957
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Chicago, Illinois 60612
Principal Investigator: Ruta Rao
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Cincinnati, Ohio 45242
Principal Investigator: Patrick Ward
Phone: 513-751-2273
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Cleveland, Ohio 44106
Principal Investigator: Paula Silverman
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Corvallis, Oregon 97330
Principal Investigator: David Hufnagel
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8196 Walnut Hill Lane
Dallas, Texas 75231
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: George Somlo
Phone: 626-359-8111
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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1901 Grandview Avenue
El Paso, Texas 79902
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Evanston, Illinois 60201
Principal Investigator: Teresa Law
Phone: 847-570-2515
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Fairfax, Virginia 22031
Principal Investigator: Neelima Denduluri
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Fayetteville, Arkansas 72703
Principal Investigator: J. Thaddeus Beck
Phone: 479-587-1700
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Fort Myers, Florida 33916
Principal Investigator: Lowell Hart
Phone: 239-274-9930
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Fort Wayne, Indiana 46815
Principal Investigator: Lakshmi Aggarwal
Phone: 260-969-7824
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Fountain Valley, California 92708
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3917 South Carolina 14
Greenville, South Carolina 29615
Principal Investigator: Mark A ORourke
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Helena, California 94574
Principal Investigator: Gregory B. Smith
Phone: 707-967-3698
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Houston, Texas 77030
Principal Investigator: Mothaffar Rimawi
Phone: 713-798-7814
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Houston, Texas 77024
Principal Investigator: Frankie Ann Holmes
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Kansas City, Missouri 64111
Principal Investigator: Timothy Pluard
Phone: 816-932-9644
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La Jolla, California 92037
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La Jolla, California 92093
Principal Investigator: Teresa Helsten
Phone: 858-822-4171
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Elizabeth Horenkamp
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Naperville, Illinois 60540
Principal Investigator: Joseph Kash
Phone: 630-646-6072
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Nashville, Tennessee 37203
Principal Investigator: Denise A. Yardley
Phone: 615-329-7497
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New Brunswick, New Jersey 08901
Principal Investigator: Deborah Toppmeyer
Phone: 732-235-9659
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600 Celebrate Life Parkway
Newnan, Georgia 30265
Principal Investigator: Ricardo Alvarez
Phone: 770-400-7194
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Olympia, Washington 98502
Principal Investigator: Linli Xuan
Phone: 360-352-2900
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Owosso, Michigan 48867
Principal Investigator: Tallat Mahmood
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Richardson, Texas 75082
Principal Investigator: Alan Trumbly
Phone: +1 214 947 14452
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Richmond, Virginia 23235
Principal Investigator: James Khatcheressian
Phone: 804-287-3000
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Principal Investigator: Gail L. Wright
Phone: 239-275-9687
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Salt Lake City, Utah 84112
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San Antonio, Texas 78229
Principal Investigator: Virginia Kaklamani
Phone: 210-450-1789
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San Diego, California 92120
Principal Investigator: Jonathan Polikoff
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San Francisco, California 94143
Principal Investigator: Michelle Melisko
Phone: 415-353-7618
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Sioux Falls, South Dakota 57105
Principal Investigator: Amy Krie
Phone: 605-322-3095
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Skokie, Illinois 60076
Principal Investigator: Ira Oliff
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Tacoma, Washington 98405
Principal Investigator: Anuradha Belur
Phone: 253-697-4875
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Topeka, Kansas 66606
Principal Investigator: Andrew Jameel Meyer
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Tyler, Texas 75702
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Wenatchee, Washington 98801
Principal Investigator: Lindsay Overton
Phone: +1 509 663 8711 x 5014
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Wyoming, Michigan 49519
Principal Investigator: Michael Zakem
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