Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/26/2017
Start Date:February 2016
End Date:April 2023
Contact:Clinical Trials Nurse Navigator
Email:ctnursenav@kumc.edu
Phone:913-945-7552

Use our guide to learn which trials are right for you!

Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer

The purpose of this study is to determine if ribociclib in combination with letrozole for 24
weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative
Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with
letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.

Subjects will be randomized (1:1:1) to either letrozole plus placebo vs. letrozole plus
continuous dosing of ribociclib vs. letrozole plus intermittent dosing
(3-weeks-on/1-week-off) of ribociclib.

The difference in clinical, pathologic and radiologic response as well as Pre-operative
Endocrine Prognostic Index (PEPI) scores across the three treatments arms will be examined.
Subjects will also be followed for 5 years post-treatment to determine if ribociclib in
combination with letrozole for 24 weeks results in improved 5 year Relapse Free Survival
(RFS) compared to letrozole alone.

Key Inclusion Criteria:

- Pathologically confirmed invasive breast cancer by core needle biopsy

- Female subjects, age ≥ 18 years

- Only postmenopausal women will be eligible.

- Performance Status: Eastern Cooperative Oncology Group (ECOG) score 0-2

- Invasive breast cancer must be ER+ in ≥66 % of the cells or ER Allred score 6-8

- Invasive breast cancer must be HER2 negative.

- Clinical Stage II or III (by clinical measurement and/or breast imaging)

Key Exclusion Criteria:

- Subjects meeting any of the exclusion criteria at baseline will be excluded from study
participation.

- Current use of other investigational agents

- Inflammatory breast cancer defined as clinically significant erythema of the breast
and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau
d'orange without erythema)

- An excisional biopsy of this breast cancer

- Surgical axillary staging procedure prior to study entry

- Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four
weeks prior to first study treatment

- Clinical or radiographic evidence of metastatic disease

- Clinically significant, uncontrolled heart disease

- Herbal preparations/medications as listed in Appendix B of the protocol
We found this trial at
13
sites
Kansas City, Kansas 66112
Phone: 913-945-7552
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
1192 East Newport Center Drive
Deerfield Beach, Florida 33442
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
Kansas City, Missouri 64131
Phone: 913-945-7552
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kansas City, Missouri 64154
Phone: 913-945-7552
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lee's Summit, Missouri 64064
Phone: 913-945-7552
?
mi
from
Lee's Summit, MO
Click here to add this to my saved trials
600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Overland Park, Kansas 66210
Phone: 913-945-7552
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Westwood, Kansas 66205
Phone: 913-945-7552
?
mi
from
Westwood, KS
Click here to add this to my saved trials