Breast CancerPhase 2FELINENCT02712723
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
A Phase 2 study testing Letrozole and Ribociclib in people with Breast Cancer, run by Qamar Khan at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole and Ribociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2016to Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Clinical or radiographic evidence of metastatic disease
- Clinically significant, uncontrolled heart disease
- Herbal preparations/medications as listed in Appendix B of the protocol
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Miami Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, 33442
City of Hope National Medical Center
Duarte, California, 91010
University of Kansas Cancer Center - West
Kansas City, Kansas, 66112
University of Kansas Cancer Center - South
Kansas City, Missouri, 64131
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
Columbia University Medical Center
New York, New York, 10032
University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, 66210
Cancer Research Collaboration
Santa Ana, California, 92705
University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Letrozole, Ribociclib, Placebo
- Keywords
- ER+, HER2-negative breast cancer, Stage II or III, Letrozole, Femara, Ribociclib, LEE011, Neo-adjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara, CGS 20267, LTZ
Nonsteroidal aromatase inhibitor
RibociclibDrug
Also called LEE011, LEE-011
Oral cyclin-dependent kinase (CDK) inhibitor
PlaceboDrug
Placebo for ribociclib
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Letrozole | Active comparator | Placebo randomized to 3 capsules/day 3 weeks on/1week off or 2 capsules/day continuous dosing + Letrozole 2.5 mg PO daily Receives: Drug: Letrozole; Drug: Placebo |
| Ribociclib 600 mg + Letrozole | Experimental | Ribociclib 600 mg PO daily 21 days on/7 days off + Letrozole 2.5 mg PO daily Receives: Drug: Letrozole; Drug: Ribociclib |
| Ribociclib 400 mg + Letrozole | Experimental | Ribociclib 400 mg continuous daily dosing + Letrozole 2.5 mg PO daily Receives: Drug: Letrozole; Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PEPI Score 0 at Surgery Between Ribociclib Containing Arms (Combined) vs. Letrozole Alone Arm.
The Preoperative Endocrine Prognostic Index (PEPI) score 0 is defined as: pT stage 0, 1, or 2 at surgery after 24 weeks of neoadjuvant therapy; negative axillary lymph nodes at surgey; Ki67 of ≤ 2.7 % at surgery; and tumor is ER+ at surgery. A PEPI score of 0 predicts a good outcome compare to PEPI score >0.
Measured: 24 weeks
Secondary outcomes (4)
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.
Measured: 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
pCR is assciated with better outcomes in breast cancer
Measured: 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
Measured: 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)
Measured: 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion27 Aug 2018
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qamar Khan
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Qamar Khan, University of Kansas Medical Center
- Investigators
- Qamar Khan, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712723
- Sponsor's protocol ID
- CLEE011XUS10T
- Acronym
- FELINE
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2016
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer
- ClinicalTrials.gov ID
- NCT02712723
- Acronym / sponsor ID
- FELINE / CLEE011XUS10T
- Conditions
- Breast Cancer
- Keywords
- ER+, HER2-negative breast cancer, Stage II or III, Letrozole, Femara, Ribociclib, LEE011, Neo-adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Qamar KhanUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2016 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo + Letrozole | Active comparator | Drug: Letrozole, Drug: PlaceboPlacebo randomized to 3 capsules/day 3 weeks on/1week off or 2 capsules/day continuous dosing + Letrozole 2.5 mg PO daily |
| Ribociclib 600 mg + Letrozole | Experimental | Drug: Letrozole, Drug: RibociclibRibociclib 600 mg PO daily 21 days on/7 days off + Letrozole 2.5 mg PO daily |
| Ribociclib 400 mg + Letrozole | Experimental | Drug: Letrozole, Drug: RibociclibRibociclib 400 mg continuous daily dosing + Letrozole 2.5 mg PO daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: Femara, CGS 20267, LTZNonsteroidal aromatase inhibitor | Drug | Placebo + Letrozole, Ribociclib 400 mg + Letrozole, Ribociclib 600 mg + Letrozole |
| RibociclibAlso: LEE011, LEE-011Oral cyclin-dependent kinase (CDK) inhibitor | Drug | Ribociclib 400 mg + Letrozole, Ribociclib 600 mg + Letrozole |
| PlaceboPlacebo for ribociclib | Drug | Placebo + Letrozole |
Primary outcome
Rate of PEPI Score 0 at Surgery Between Ribociclib Containing Arms (Combined) vs. Letrozole Alone Arm.
Time frame: 24 weeks
The Preoperative Endocrine Prognostic Index (PEPI) score 0 is defined as: pT stage 0, 1, or 2 at surgery after 24 weeks of neoadjuvant therapy; negative axillary lymph nodes at surgey; Ki67 of ≤ 2.7 % at surgery; and tumor is ER+ at surgery. A PEPI score of 0 predicts a good outcome compare to PEPI score >0.
4 secondary outcomes
Rate of Complete Cell Cycle Arrest at 2 Weeks Between Ribociclib Containing Arms (Combined) vs Letrozole Alone Arm.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qamar Khan, MD principal investigator
University of Kansas Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole and Ribociclib in people with Breast Cancer, run by Qamar Khan at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PEPI Score 0 at Surgery Between Ribociclib Containing Arms (Combined) vs. Letrozole Alone Arm. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.