Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
NCT ID: NCT02712723
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
121 participants
INTERVENTIONAL
2016-02-29
2023-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Letrozole
Nonsteroidal aromatase inhibitor
Placebo
Placebo for ribociclib
Ribociclib 600 mg + Letrozole
Ribociclib 600 mg PO daily 21 days on/7 days off + Letrozole 2.5 mg PO daily
Letrozole
Nonsteroidal aromatase inhibitor
Ribociclib
Oral cyclin-dependent kinase (CDK) inhibitor
Ribociclib 400 mg + Letrozole
Ribociclib 400 mg continuous daily dosing + Letrozole 2.5 mg PO daily
Letrozole
Nonsteroidal aromatase inhibitor
Ribociclib
Oral cyclin-dependent kinase (CDK) inhibitor
Interventions
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Letrozole
Nonsteroidal aromatase inhibitor
Ribociclib
Oral cyclin-dependent kinase (CDK) inhibitor
Placebo
Placebo for ribociclib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Qamar Khan
OTHER
Responsible Party
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Qamar Khan
Associate Professor
Principal Investigators
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Qamar Khan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope National Medical Center
Duarte, California, United States
Cancer Research Collaboration
Santa Ana, California, United States
University of Miami Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, United States
University of Kansas Cancer Center - West
Kansas City, Kansas, United States
University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Kansas Cancer Center - South
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Columbia University Medical Center
New York, New York, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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CLEE011XUS10T
Identifier Type: -
Identifier Source: org_study_id
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