Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer (FELINE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02712723 |
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Recruitment Status :
Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : August 29, 2019
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Sponsor:
Qamar Khan
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Qamar Khan, University of Kansas Medical Center
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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 |
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 : | 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
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Letrozole
Nonsteroidal aromatase inhibitor
Other Names:
Drug: Placebo Placebo for ribociclib |
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Experimental: Ribociclib 600 mg + Letrozole
Ribociclib 600 mg PO daily 21 days on/7 days off + Letrozole 2.5 mg PO daily
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Drug: Letrozole
Nonsteroidal aromatase inhibitor
Other Names:
Drug: Ribociclib Oral cyclin-dependent kinase (CDK) inhibitor
Other Names:
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Experimental: Ribociclib 400 mg + Letrozole
Ribociclib 400 mg continuous daily dosing + Letrozole 2.5 mg PO daily
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Drug: Letrozole
Nonsteroidal aromatase inhibitor
Other Names:
Drug: Ribociclib Oral cyclin-dependent kinase (CDK) inhibitor
Other Names:
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Primary Outcome Measures :
- 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 :
- 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 ]
- 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) ]
- 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) ]
- 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
| 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
| Principal Investigator: | Qamar Khan, MD | University of Kansas Medical Center |
| 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:
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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 |