- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02712723
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer (FELINE)
Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
California
-
Duarte, California, United States, 91010
- City of Hope National Medical Center
-
Santa Ana, California, United States, 92705
- Cancer Research Collaboration
-
-
Florida
-
Deerfield Beach, Florida, United States, 33442
- University of Miami Sylvester Comprehensive Cancer Center
-
-
Kansas
-
Kansas City, Kansas, United States, 66112
- University of Kansas Cancer Center - West
-
Overland Park, Kansas, United States, 66210
- University of Kansas Cancer Center - Overland Park
-
Westwood, Kansas, United States, 66205
- University of Kansas Cancer Center - Westwood
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Missouri
-
Kansas City, Missouri, United States, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, United States, 64131
- University of Kansas Cancer Center - South
-
Lee's Summit, Missouri, United States, 64064
- University of Kansas Cancer Center - Lee's Summit
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin Carbone Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Placebo + Letrozole
Placebo randomized to 3 capsules/day 3 weeks on/1week off or 2 capsules/day continuous dosing + Letrozole 2.5 mg PO daily
|
Nonsteroidal aromatase inhibitor
Other Names:
Placebo for ribociclib
|
Experimental: Ribociclib 600 mg + Letrozole
Ribociclib 600 mg PO daily 21 days on/7 days off + Letrozole 2.5 mg PO daily
|
Nonsteroidal aromatase inhibitor
Other Names:
Oral cyclin-dependent kinase (CDK) inhibitor
Other Names:
|
Experimental: Ribociclib 400 mg + Letrozole
Ribociclib 400 mg continuous daily dosing + Letrozole 2.5 mg PO daily
|
Nonsteroidal aromatase inhibitor
Other Names:
Oral cyclin-dependent kinase (CDK) inhibitor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Pre-operative Endocrine Prognostic Index (PEPI) score 0 at surgery between ribociclib containing arms (combined) vs letrozole alone arm
Time Frame: At Surgery (22 weeks)
|
At Surgery (22 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of complete cell cycle arrest at 2 weeks between ribociclib containing arms (combined) vs letrozole alone arm: Complete cell cycle arrest is defined as Ki67 at day 14 of < 2.7%
Time Frame: Day 14 of Cycle 1
|
Day 14 of Cycle 1
|
Pathologic complete response rate (pCR rate): pCR rate is defined as the proportion of patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes
Time Frame: At Surgery (Days 8-15 of Cycle 6)
|
At Surgery (Days 8-15 of Cycle 6)
|
Clinical complete response rate (cCR rate): cCR rate is defined as the proportion of patients with no residual tumor by clinical exam
Time Frame: Post-surgery (Once in the first 4 weeks of post-op, then once every 6 months for 5 years post-op)
|
Post-surgery (Once in the first 4 weeks of post-op, then once every 6 months for 5 years post-op)
|
5 Year Relapse Free Survival (RFS)
Time Frame: 5 years post-treatment
|
5 years post-treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
Other Study ID Numbers
- CLEE011XUS10T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
Clinical Trials on Letrozole
-
Helsinki University Central HospitalFoundation for Paediatric Research, FinlandCompletedConstitutional Delay of Growth and PubertyFinland
-
Rovi Pharmaceuticals LaboratoriesRecruiting
-
Institut du Cancer de Montpellier - Val d'AurelleNovartisCompleted
-
University of Alabama at BirminghamGenentech, Inc.; Breast Cancer Research FoundationCompletedBreast Cancer | Breast Neoplasm | Cancer of the BreastUnited States
-
Fudan UniversityRecruitingEndometrial CancerChina
-
Wyeth is now a wholly owned subsidiary of PfizerPfizerCompletedBreast Neoplasms
-
IVI MadridActive, not recruitingLuteinised Follicular CystSpain
-
Assiut UniversityRecruitingInfertility, FemaleEgypt
-
Novartis PharmaceuticalsCompletedBreast NeoplasmUnited States, Germany, Spain, United Kingdom, France, Austria, Russian Federation, Italy, Canada, Belgium
-
Cairo UniversityAhmed Elgazzar HospitalCompleted