Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:November 29, 2016
End Date:May 21, 2021

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COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

The purpose of this Phase IIIb study is to collect additional safety and efficacy data for
the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2-
advanced breast cancer.


Inclusion Criteria:

- Male or female advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy.

- In the case of women, both pre/perimenopausal and postmenopausal patients are allowed
to be included in this study; menopausal status is relevant for the requirement of
goserelin to be used concomitantly with ribociclib and letrozole.

1. Postmenopausal status is defined either by:

I). Prior bilateral oophorectomy OR ii). Age ≥ 60 OR iii). Age < 60 and
amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen,
toremifen, or ovarian suppression) and FSH and 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 with therapy-induced amenorrhea, serial measurements of FSH
and/or estradiol are needed to ensure menopausal status.

2. Premenopausal status is defined as either:

I). Patient had last menstrual period within the last 12 months, OR ii). If on
tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be
in the premenopausal range per local normal range, OR iii). In case of therapy
induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal
range per local normal range.

3. Perimenopausal status is define as neither premenopausal nor postmenopausal Note:
Throughout this document, perimenopausal and premenopausal status is grouped
together and referred as "Premenopausal"

- Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer by
local laboratory.

- Patient has HER2-negative breast cancer defined as a negative in situ hybridization
test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization
(FISH, CISH, or SISH) test is required by local laboratory testing.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

- Patient has adequate bone marrow and organ function as defined by ALL of the following
laboratory values (as assessed by local laboratory):

- Absolute neutrophil count ≥ 1.5 × 10^9/L

- Platelets ≥ 100 × 10^9/L

- Hemoglobin ≥ 9.0 g/dL

- Potassium, sodium, calcium corrected for serum albumin and magnesium within
normal limits or corrected to within normal limits with supplements before first
dose of the study medication

- INR ≤1.5

- Serum creatinine <1.5 mg/dl or creatinine clearance≥50 mL/min

- In absence of liver metastases, alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver
metastases, ALT and AST should be < 5 × ULN.

- Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin
within normal range in patients with well-documented Gilbert's Syndrome

- Patient must have a 12-lead ECG with ALL of the following parameters at screening:

- QTcF interval at screening <450 msec (using Fridericia's correction)

- Resting heart rate ≥ 50 bpm

Exclusion Criteria:

- Patient who received any CDK4/6 inhibitor

- Patient who received any prior systemic hormonal therapy for advanced breast cancer;
no more than one prior regimen of chemotherapy for the treatment of metastatic disease
is permitted

Note:

- Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the
prior neo (adjuvant) therapy included letrozole or anastrozole the disease free
interval must be greater than 12 months from the completion of treatment until study
entry.

- Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior
to inclusion in this trial are eligible.

- Any prior (neo) adjuvant anti-cancer therapy or prior chemotherapy for metastatic
disease must be stopped at least 5 half-lives or 7 days, whichever is longer, before
study inclusion.

- Patient is concurrently using other anti-cancer therapy.
We found this trial at
73
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
Phone: 253-396-5329
2013
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Tacoma, WA
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Albuquerque, New Mexico 87109
Principal Investigator: Ursa Brown-Glaberman
Phone: 505-925-0357
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Anchorage, AK
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6701 North Charles Street
Baltimore, Maryland 21204
Principal Investigator: Madhu Chaudhry
Phone: 443-849-3051
342
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Baltimore, MD
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Bellingham, Washington 98225
Principal Investigator: Patrick Nestor
Phone: 360-788-8238
2015
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Beverly Hills, California 90211
Principal Investigator: Julio Peguero
Phone: 310-432-8900
1979
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1055 N Curtis Rd
Boise, Idaho 83706
(208) 367-2121
Principal Investigator: Kerry Pulver
Phone: 208-367-7070
Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
1715
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Boise, ID
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Bronx, New York 10469
Principal Investigator: Fabio Voltera
Phone: 718-732-4000
486
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Caba, Buenos Aires
5386
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Caba,
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Canton, Ohio 44710
Principal Investigator: Shruti Trehan
Phone: 330-489-9053
102
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Chandler, Arizona 85224
Principal Investigator: Mikhail I Shtivelband
Phone: 480-855-2225
1655
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2711 Randolph Road
Charlotte, North Carolina 28207
Principal Investigator: Justin Favaro
Phone: 704-342-1900
350
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214 East 23rd Street
Cheyenne, Wyoming 82001
Principal Investigator: Natalie Alana Workman
Phone: 307-634-9311
1143
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Chicago, Illinois 60612
Principal Investigator: Thomas Lad
Phone: 312-864-7257
274
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2123 Auburn Avenue
Cincinnati, Ohio 45219
Principal Investigator: Robert Cody
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11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Paula Silverman
Phone: 216-844-8510
129
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Cleveland, OH
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126
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Davie, Florida 33328
Principal Investigator: Elizabeth Tan-Chiu
Phone: 954-582-1850
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2525 South Downing Street
Denver, Colorado 80210
Principal Investigator: Mikhaeel-Kamel Nadine
Phone: 303-715-7030
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Elizabeth, New Jersey 07207
Principal Investigator: Gerardo Capo
Phone: 908-994-8775
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Elizabeth, NJ
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Principal Investigator: Jill Morrison
Phone: 201-568-5250
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
479
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Englewood, NJ
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1700 13th Street
Everett, Washington 98201
Principal Investigator: Peter Jiang
Phone: 425-261-3499
2001
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Farmington, New Mexico 87401
Principal Investigator: Syed Kazmi
Phone: 505-564-6874
1379
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Fayetteville, Arkansas 72703
Principal Investigator: J. Thaddeus Beck
Phone: 479-587-1700
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555 East Cheves Street
Florence, South Carolina 29506
Principal Investigator: Karim Tazi
Phone: 843-777-7951
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2315 East Harmony Road
Fort Collins, Colorado 80528
Principal Investigator: Diane C. Medgyesy
Phone: 970-297-6150
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Glenwood Springs, Colorado 81601
Principal Investigator: Armando Armas
Phone: 561-577-2112
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Goshen, Indiana 46526
Principal Investigator: Daniel Bruetman
Phone: 574-364-2974
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17323 Red Oak Drive
Houston, Texas 77090
Principal Investigator: Isaac Levy
Phone: 354-266-7885
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Houston, Texas 77090
Principal Investigator: Anirudha Dasgupta
Phone: 281-440-5006
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Jackson, Mississippi 39202
Principal Investigator: Grace G. Shumaker
Phone: 601-974-5547
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2614 West Jefferson Street
Joliet, Illinois 60435
Principal Investigator: Jason Suh
Phone: 815-725-1355
288
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
Principal Investigator: Gary Doolittle
620
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Kennewick, Washington 99336
Principal Investigator: Rangaswamy Chintapatla
Phone: 509-783-0144
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1382 East Stroop Road
Kettering, Ohio 45409
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Lake Success, New York 11042
Principal Investigator: Morton Coleman
Phone: 516-488-2918
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1730 Lakeland Hills Boulevard
Lakeland, Florida 33805
Principal Investigator: Neeharika Makani
Phone: 863-603-4747
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Las Vegas, Nevada 89109
Principal Investigator: MaryAnn K Allison
Phone: 702-856-1401
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Lincoln, Nebraska 68506
Principal Investigator: Mark Hutchins
Phone: 402-484-4908
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Long Beach, California 90813
Principal Investigator: Danny Nguyen
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Los Angeles, California 90033
Principal Investigator: Janice Lu
Phone: 323-865-3955
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10110 Don S Powers Dr
Munster, Indiana 46321
Principal Investigator: Erwin Robin
Phone: 219-924-8178
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1514 Jefferson Highway
New Orleans, Louisiana 70121
Principal Investigator: John T. Cole
Phone: 504-842-3708
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Principal Investigator: Michael A. Danso
Phone: 757-873-9833
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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407 Vernon Avenue
Normal, Illinois 61761
Principal Investigator: John Migas
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Omaha, Nebraska 68154
Principal Investigator: Margaret Barbara Block
Phone: +1 402 334 4773
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2776 Enterprise Rd # 100
Orange City, Florida 32763
Principal Investigator: Santosh Nair
Phone: 386-774-1223
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10600 South Quivira Road
Overland Park, Kansas 66209
Principal Investigator: Stephanie L Graff
Phone: 816-805-2281
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Oxnard, California 93030
Principal Investigator: Lynn Kong
Phone: 805-485-8709
2017
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Paramus, New Jersey 07652
Principal Investigator: Thomas Rakowski
Phone: 201-634-5792
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Phoenix, Arizona 85016
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Pismo Beach, California 93449
Principal Investigator: David Palchak
Phone: 805-474-9143
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195 Fore River Parkway
Portand, Maine 04102
Principal Investigator: Roger Inhorn
Phone: 207-553-6865
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Portland, Oregon 97239
Principal Investigator: Zahi Mitri
Phone: 503-418-9736
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400 South 43rd Street
Renton, Washington 98055
Principal Investigator: Navanshu Arora
Phone: 425-656-5570
2001
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1583 Health Care Drive
Rock Hill, South Carolina 29732
Principal Investigator: Sashi Naidu
Phone: 803-329-7772
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9905 Medical Center Drive
Rockville, Maryland 20850
Principal Investigator: Tejaswi R Sastry
316
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Rockville, Maryland 20850
Principal Investigator: Leon Hwang
Phone: 240-632-4817
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San Antonio, Texas 78229
Principal Investigator: Virginia Kaklamani
Phone: 210-450-3838
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San Francisco, California 94120
Principal Investigator: Wei Wang
Phone: 415-885-8600
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Savannah, Georgia 31405
Principal Investigator: Mark Taylor
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Seattle, Washington 98101
Principal Investigator: Nanette Robinson
2006
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230 Nebraska Street
Sioux City, Iowa 51101
Principal Investigator: Donald B. Wender
Phone: 712-252-0088
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75 Veronica Avenue
Somerset, New Jersey 08873
Principal Investigator: Naveed Aslam
Phone: 248-435-8000
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915 Gordon Avenue
Thomasville, Georgia 31792
Principal Investigator: Josh D. Simmons
Phone: 229-584-5400
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17333 South La Grange Road
Tinley Park, Illinois 60487
Principal Investigator: Subramanya Rao
Phone: 708-745-9971
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1620 West Saint Mary’s Road
Tucson, Arizona 85745
Principal Investigator: Rachel E. Swart
Phone: +1 513 585 0844
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Tulsa, Oklahoma 74136
Principal Investigator: Kevin Weibel
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721 Clinic Drive
Tyler, Texas 75701
Principal Investigator: Arielle Lee
Phone: 903-595-7041
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2300 M Street Northwest
Washington DC, Maryland 20037
Principal Investigator: Rebecca Kaltman
Phone: +1 202 677 6216
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