Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:August 14, 2017
End Date:September 30, 2020
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After CDK 4/6 Inhibitor Treatment

Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+,
HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6
treatment with an aromatase inhibitor (AI) or fulvestrant


Inclusion Criteria:

- Patient is male or female 18 years or older

- Males or females with advanced (locoregionally recurrent or metatstatic) breast cancer
not amenable to curative therapy

- In case of women, both premenopausal and postmenopausal patients are allowed to be
included in study; menopausal status is relevant for the requirement of LHRH agonist
(examples for use in this study include but not limited to goserelin, leuprolide or
locally available treatment) to be used concomitantly with alpelisib and
letrozole/fulvestrant

1. Patient is postmenopausal woman defined as either:

- Prior bilateral oophorectomy or

- Age ≥60 or

- Age <60 and amenorrhea for 12 or more months (in the absence of
chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and/or
estradiol in the postmenopausal range per local normal range.

If patient is taking tamoxifen or toremifene and age <60, then FSH and plasma
estradiol levels should be in post-menopausal range per local normal range.

Note: For women using therapy-induced amenorrhea other than ovarian radiation,
goserelin or leuprolide, etc., serial measurements of FSH and/or estradiol are
needed to ensure menopausal status

2. Patient is premenopausal defined as either:

- Patient had last menstrual period within the last 12 months or

- If on tamoxifen or toremifene with in the past 14 days, plasma estradiol and
FSH must be in the premenopausal range per local normal range, or

- In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be
in the premenopausal range per local normal range

- Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC

- Patient has confirmed HER2-negative advanced breast cancer (aBC)

- Patient has a PIK3CA mutation confirmed by Novartis designated central lab or patient
has a pathology report confirming PIK3CA mutant status by certified laboratory (using
validated PI3KCA mutation assay) either from tissue or blood and must (mandatory) send
tumor tissue to Novartis designated central lab for confirmation of mutational status

- Patient must have:

- Documented evidence of tumor progression on or after CDK 4/ 6 inhibitor
combination treatment; CDK 4/6 inhibitor must be the last treatment regimen prior
to study entry,

- No more than two (2) prior anti-cancer therapies for aBC

- Received no more than one prior regimen of chemotherapy in the metastatic setting

- Patient has either measurable disease per RECIST v1.1 or at least one predominantly
lytic bone lesion must be present

- ECOG performance status ≤ 2

- Patient has fasting plasma glucose (FPG) ≤140 mg/dL (7.7 mmol/L) and glycosylated
hemoglobin (HbA1c) ≤ 6.4% (both criteria have to be met)

- Patient has adequate bone marrow, coagulation, liver and renal function

Exclusion Criteria:

- patient has known hypersensitivity to alpelisib, fulvestrant or letrozole

- Patient has received prior treatment with any PI3K inhibitors

- Patient with an established diagnosis of diabetes mellitus type I or uncontrolled type
II

- Patient has a concurrent malignancy or malignancy within 3 years of study screening
period, with the exception of adequately treated, basal or squamous cell carcinoma,
non-melanoma skin cancer or curatively resected cervical cancer

- Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation
≤ 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from
related side effects of such therapy

- History of acute pancreatitis within 1 year of screening or past medical history of
pancreatitis

- Patients with central nervous system (CNS) involvement unless they meet ALL of the
following criteria:

- At least 4 weeks from prior therapy completion (including radiation and/or
surgery) to starting the study treatment

- Clinically stable CNS tumor at the time of screening untreated or without
evidence of progressions for at least 4 weeks after treatment as determined by
clinical examination and brain imaging (MRI or CT) during screening period and
stable low dose of steroids for 2 weeks prior to initiating study treatment

- Patient with severe liver impairment (Child Pugh score B/C)

- Patient has impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of the study drugs

- Patient has documented pneumonitis which is active and requiring treatment

- Patient has a history of Stevens-Johnson-Syndrome (SJS) or Toxic Epidermal Necroloysis
(TEN)

- Patient is concurrently using other anti-cancer therapy. All anti-cancer therapy must
be discontinued prior to day one of study treatment.
We found this trial at
27
sites
11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Paula Silverman
Phone: 216-844-5176
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820 North Chelan Avenue
Wenatchee, Washington 98801
509) 663-8711
Principal Investigator: Lindsay Overton
Phone: 509-665-5800
Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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Albuquerque, New Mexico 87109
Principal Investigator: Ursa Brown-Glaberman
Phone: 505-925-0366
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Anaheim, California 92807
Principal Investigator: Jennifer Carney
Phone: 808-432-8587
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: David Andrew Riseberg
Phone: 410-332-1200
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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6701 North Charles Street
Baltimore, Maryland 21204
443-849-3051
Principal Investigator: Madhu Chaudhry
Phone: 410-528-3058
Greater Baltimore Medical Center Cancer Center The Sandra & Malcolm Berman Cancer Institute's comprehensive, multidisciplinary...
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Beverly Hills, California 90211
Principal Investigator: Linea Chap
Phone: 310-432-8900
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Billings, Montana 59102
Principal Investigator: Patrick Cobb
Phone: 406-238-6962
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Boston, Massachusetts 02114
Principal Investigator: Dejan Juric
Phone: 617-724-0878
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Principal Investigator: Corrine Zarwan
Phone: 781-744-2500
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Caba, Buenos Aires
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Detroit, Michigan 48202
Principal Investigator: Haythem Ali
Phone: 313-916-2438
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Gilbert, Arizona 85234
Principal Investigator: Shakeela Bahadur
Phone: *see departments*
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Sneha Phadke
Phone: 319-356-1826
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kansas City, Kansas 66160
Principal Investigator: Qamar J Khan
Phone: 913-945-5052
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Los Angeles, California 90033
Principal Investigator: Janice Lu
Phone: 323-865-3955
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601 South Floyd Street
Louisville, Kentucky 40202
Principal Investigator: Mounika Mandadi
Phone: 502-562-4356
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New Haven, Connecticut 06520
Principal Investigator: Andrea Silber
Phone: 203-737-2848
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New York, New York 10065
Principal Investigator: Pamela Drullinsky
Phone: 646-888-5341
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Orange, California 92868
Principal Investigator: Ritesh Parajuli
Phone: 714-456-3489
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Orlando, Florida 32804
Principal Investigator: Carlos A. Alemany
Phone: 407-303-3235
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Phoenix, Arizona 85054
Principal Investigator: Donald W Northfelt
Phone: 480-342-6429
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7703 Floyd Curl Drive
San Antonio, Texas 78229
Principal Investigator: Virginia Kaklamani
Phone: 210-450-1366
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San Diego, California 92108
Principal Investigator: Jonathan Polikoff
Phone: 619-528-3955
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San Francisco, California 94143
Principal Investigator: Hope S Rugo
Phone: 415-885-3789
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Santa Ana, California 92705
Principal Investigator: John Link
Phone: 562-981-6101
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
Phone: 253-396-5329
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