A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:December 7, 2018
End Date:December 26, 2025
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of
ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early
Breast Cancer


Inclusion

- Patient is ≥ 18 years-old at the time of PICF signature

- Patient is female with known menopausal status at the time of PICF signature or
initiation of adjuvant ET (whichever occurs earlier), or male.

- Patient with histologically confirmed unilateral primary invasive adenocarcinoma of
the breast with a date of initial cytologic or histologic diagnosis within 18 months
prior to randomization.

- Patient has breast cancer that is positive for ER and/or PgR

- Patient has HER2-negative breast cancer

- Patient has available archival tumor tissue from the surgical specimen

- Patient after surgical resection where tumor was removed completely, with the final
surgical specimen microscopic margins free from tumor, and who belongs to one of the
following categories (anatomic stage group II or III)

- If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according
to the institutional guidelines

- If indicated, patient has completed adjuvant radiotherapy according to the
institutional guidelines

- Patient has no contraindication for the adjuvant ET in the trial and is planned to be
treated with ET for 5 years

Exclusion

- Patient has received any CDK4/6 inhibitor

- Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction
in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within
the last 2 years prior to PICF signature

- Patient has received prior treatment with anthracyclines at cumulative doses of 450
mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin. Patient with a
known hypersensitivity to any of the excipients of ribociclib and/or ET

- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV
according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.

- Patient is concurrently using other anti-neoplastic therapy with the exception of
adjuvant ET

- Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to
randomization

- Patient has not recovered from clinical and laboratory acute toxicities related to
prior anti-cancer therapies

- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose
treatment was completed within 2 years before PICF signature

- Patient has known HIV infection, Hepatitis B or C infection

- Clinically significant, uncontrolled heart disease and/or cardiac repolarization
abnormality

- Patient is currently receiving any of the following substances within 7 days before
randomization - Concomitant medications, herbal supplements, and/or fruits that are
known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow
therapeutic window and are predominantly metabolized through CYP3A4/5

- is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to
starting trial treatment

- Patient has impairment of GI function or GI disease that may significantly alter the
absorption of the oral trial treatments

- Patient has any other concurrent severe and/or uncontrolled medical condition that
would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate
patient participation in the clinical trial or compromise compliance with the protocol

- Patient participated in another interventional study and received treatment with an
investigational product (or used an investigational device) within 30 days prior to
randomization or within 5 half-lives of the investigational product, whichever is
longer.

- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or
breast-feed during the trial.
We found this trial at
31
sites
3700 Johnson Street
Hollywood, Florida 33021
Principal Investigator: Aurelio Castrellon
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Principal Investigator: Sunil Babu
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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Fort Wayne, IN
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Bakersfield, California 93309
Principal Investigator: Ravindranath Patel
Phone: 661-616-1619
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Beverly Hills, California 90212
Principal Investigator: Nicholas McAndrew
Phone: 310-794-6500
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Burbank, California 91505
Principal Investigator: Nicholas McAndrew
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Encino, California 91436
Principal Investigator: Nicholas McAndrew
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Fort Worth, Texas 76104
Principal Investigator: Robin Ruble Young
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Goodyear, Arizona 85338
Principal Investigator: Cynthia Lynch
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Goodyear, AZ
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Laguna Hills, California 92653
Principal Investigator: Nicholas McAndrew
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Stephani Christensen
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Principal Investigator: Anna Litvak
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Livingston, NJ
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4005 Verdugo Road
Los Angeles, California 90057
Principal Investigator: Lasika Chandradatta Seneviratne
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Los Angeles, California 91405
Principal Investigator: Thomas Lomis
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Denise A Yardley
Phone: 615-329-7274
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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100 Grand St
New Britain, Connecticut 06050
(860) 224-5011
Principal Investigator: Wylie Hosmer
The Hospital of Central Connecticut The Hospital of Central Connecticut is dedicated to fostering, sustaining...
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Norwich, Connecticut 06360
Principal Investigator: Anca Bulgaru
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Orlando, Florida 32806
Principal Investigator: Ana Elisa Cuesta Fernandez
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Pasadena, California 94110
Principal Investigator: Nicholas McAndrew
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Porter Ranch, California 91326
Principal Investigator: Nicholas McAndrew
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Redondo Beach, California 90277
Principal Investigator: David Chan
Phone: 310-750-3300
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Saint Louis Park, Minnesota 55416
Principal Investigator: Rachel Lerner
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Santa Maria, California 93454
Principal Investigator: Robert Dichmann
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Santa Monica, California 90404
Principal Investigator: Nicholas McAndrew
Phone: 301-206-8309
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Tallahassee, Florida 32308
Principal Investigator: Viralkumar Bhanderi
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Torrance, California 90509
Principal Investigator: Nicholas McAndrew
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Truckee, California 96161
Principal Investigator: Ahrin Koppel
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Valencia, California
Principal Investigator: Nicholas McAndrew
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West Hills, California 91307
Principal Investigator: Ashkan Lashkari
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Westlake Village, California 91361
Principal Investigator: Nicholas McAndrew
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Principal Investigator: Shaker R. Dakhil
Phone: 316-262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Yorba Linda, California 92886
Principal Investigator: William Lawler
Phone: 714-446-5900
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