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

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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
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Overland Park, Kansas 66210
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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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...
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1192 East Newport Center Drive
Deerfield Beach, Florida 33442
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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...
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Kansas City, Kansas 66112
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Kansas City, Missouri 64131
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Kansas City, Missouri 64154
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Lee's Summit, Missouri 64064
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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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...
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Santa Ana, California 92705
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Westwood, Kansas 66205
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