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

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ClinicalTrials.gov Identifier: NCT02712723
Recruitment Status : Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Qamar Khan, University of Kansas Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole Drug: Ribociclib Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer
Study Start Date : February 2016
Actual Primary Completion Date : August 27, 2018
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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
Drug: Letrozole
Nonsteroidal aromatase inhibitor
Other Names:
  • Femara
  • CGS 20267
  • LTZ

Drug: Placebo
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
Drug: Letrozole
Nonsteroidal aromatase inhibitor
Other Names:
  • Femara
  • CGS 20267
  • LTZ

Drug: Ribociclib
Oral cyclin-dependent kinase (CDK) inhibitor
Other Names:
  • LEE011
  • LEE-011

Experimental: Ribociclib 400 mg + Letrozole
Ribociclib 400 mg continuous daily dosing + Letrozole 2.5 mg PO daily
Drug: Letrozole
Nonsteroidal aromatase inhibitor
Other Names:
  • Femara
  • CGS 20267
  • LTZ

Drug: Ribociclib
Oral cyclin-dependent kinase (CDK) inhibitor
Other Names:
  • LEE011
  • LEE-011




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. 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) ]
  4. 5 Year Relapse Free Survival (RFS) [ Time Frame: 5 years post-treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712723


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Cancer Research Collaboration
Santa Ana, California, United States, 92705
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, United States, 33442
United States, Kansas
University of Kansas Cancer Center - West
Kansas City, Kansas, United States, 66112
University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States, 66210
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States, 66205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
University of Kansas Cancer Center - South
Kansas City, Missouri, United States, 64131
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Qamar Khan
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Qamar Khan, MD University of Kansas Medical Center

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Responsible Party: Qamar Khan, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02712723     History of Changes
Other Study ID Numbers: CLEE011XUS10T
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Qamar Khan, University of Kansas Medical Center:
ER+, HER2-negative breast cancer
Stage II or III
Letrozole
Femara
Ribociclib
LEE011
Neo-adjuvant
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs