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Locoregional RecurrencePhase 2RaPhLRRNCT05467891

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

A Phase 2 study testing Ribociclib, Fulvestrant and Anastrozole in people with Locoregional Recurrence and Hormone Receptor-positive Breast Cancer, run by Oana Danciu at 21 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ribociclib, Fulvestrant and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
21 sitesUnited States
Study dates
13 Sep 2022to 15 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent (stage II/ main consent) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Male or female age ≥ 18 years at the time of consent. NOTE: Both pre- and post-menopausal women are eligible. Post-menopausal status is defined as:
  • Prior bilateral oophorectomy
  • Age ≥60
  • Age <60 and amenorrhea for the last 12 or more months(in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range.
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  • ECOG Performance Status of 0-1 within 28 days prior to registration.
  • If patient is receiving tamoxifen or toremifene, a washout period of 5 half-lives (i.e. 35 days) prior to registration is required (during that period the participant can take AI).
  • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
  • Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.
  • Patients have had adequate local treatment for locoregional recurrence (LRR) of breast cancer.
  • Locoregional recurrence is defined as recurrence in the ipsilateral breast, axilla, regional lymph nodes, or chest wall.
  • Local treatment is defined as either surgery, radiation therapy, or a combination of both if indicated.
  • Adequate local therapy is surgery with negative microscopic margins. Radiation therapy is mandated for patients with microscopically involved margins and recommended for all patients who had not received radiotherapy as part of their primary treatment.
  • Patients who have distant metastatic disease will not be eligible.
  • Prior treatment with neoadjuvant and adjuvant chemotherapy and ET is allowed.
  • Patients must enroll within 6 months of the last local treatment, either local surgery or radiation; or systemic chemotherapy (if patient is receiving chemotherapy), whichever occurred last. Chemotherapy after local therapy is allowed. ET for recurrent disease is allowed for up to 12 months prior to enrollment.
  • Patient has no contraindication to the adjuvant ET in the trial and is planned to be treated or continue treatment with ET.
  • Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
  • Hematological
  • Absolute Neutrophil Count (ANC): ≥ 1.5 x 109/L
  • Platelets: ≥ 100 x 109/L
  • Hemoglobin (Hgb): ≥ 9.0 g/dL
  • Renal
  • ---Estimated glomerular filtration rate (eGFR): ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula
  • Hepatic
  • Bilirubin: ≤ upper limit of normal (ULN) except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN
  • Aspartate aminotransferase (AST): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the AST is < 5 × ULN
  • Alanine aminotransferase (ALT): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the ALT is < 5 × ULN
  • Coagulation
  • ---International Normalized Ratio (INR) : ≤ 1.5 × ULN (unless is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug)
  • Electrolytes ---Potassium, Magnesium, and Total Calcium (corrected for serum albumin): Within normal limits or corrected to within normal limits with supplements.
  • Standard 12-lead ECG values defined as
  • QTcF interval at screening < 450 msec (QT interval using Fridericia's correction)
  • Resting heart rate 50-90 bpm (determined from the ECG)
  • Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration and must be willing to use a highly effective method of contraception that does not contain estrogen and/or progesterone. See the protocol for definition of childbearing potential.
  • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
  • Ability to swallow and retain oral medication.

Who cannot join

  • Subjects meeting any of the criteria below may not participate in the study:
  • Patient with a known hypersensitivity to any of the excipients of ribociclib.
  • Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
  • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
  • Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.
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  • Patients with distant metastases of breast cancer beyond regional lymph nodes as defined by AJCC (8th edition).
  • Treatment with any investigational drug within 30 days prior to registration or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. Enrollment or planned enrollment in another study that does not involve an investigational drug will be allowed at the discretion of the treating investigator.
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, HIV, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). Testing to be done at investigator's discretion.
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
  • History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry
  • Documented cardiomyopathy
  • History of Left Ventricular Ejection Fraction (LVEF) < 50%
  • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
  • Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
  • Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug)
  • Inability to determine the QTcF interval
  • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
  • Systolic Blood Pressure (SBP) >160 or <90 mmHg
  • Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:
  • Concomitant medications, herbal supplements, and/or fruits (e.g., grapefruit, pummelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5,
  • Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  • Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: a short duration (<5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • Patient with an uncontrolled psychiatric condition that, in the investigator's judgment, may cause unacceptable safety risks, impede research integrity and compliance, or interfere with the objectives of the study.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oana Danciu, MD contact

312-996-1581

ocdanciu@uic.edu

Amber Ryba contact

317-634-5842 ext. 13

aryba@hoosiercancer.org

21 sites in 1 country

United States21 sites, 19 recruiting

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87102

    Bernard Tawfik, MD, 505-272-4946, BTawfik@salud.unm.edu

    Bernard Tawfik, MD

    Recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Cancer Answer Line, 1-800-865-1125, canceranswerline@med.umich.edu

    Kathleen Kemmer, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Kyndall Thomas, kyndallrthomas@uabmc.edu

    Nusrat Jahan, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Larkin De Laria, larkin.delaria@tuftsmedicine.org

    Don Dizon, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Alex M Jones, 843-792-5573, joalex@musc.edu

    Abirami Sivapiragasam, MD

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

    Olena Glushakova, oyg2n@uvahealth.org

    Trish Millard, MD

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

    Erin Vidra, 312-996-7902, evidra@uic.edu

    Oana Danciu, MD

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Emily Viall, Emily.Viall@osumc.edu

    Ashley Davenport, MD

    Recruiting

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

    Kari Schultz, 260-266-9252, kari.schultz@parkview.com

    Melanie Clark, MD

    Recruiting

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

    Monali Vasekar, MD, Penn-CTO@pennstatehealth.psu.edu

    Monali Vasekar, MD

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Katie Carius, katie-carius@uiowa.edu

    Sneha Phadke, DO

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53705

    Danae Wolff, 608-262-0803, danae.wolff@wisc.edu

    Kari Wisinski, MD

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Yue Wang, MD, PhD, 973-972-3681, yw670@cinj.rutgers.edu

    Coral Omene, MD

    Recruiting

  • New York University Clinical Cancer Center

    New York, New York, 10016

    Manju P Rajan, 929-455-2435, pamela.rajan@nyulangone.org

    Nancy Chan, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Shelly Aust, shelly.aust@unmc.edu

    Amulya Yellala, MBBS

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Active, not recruiting

  • University of Arizona

    Phoenix, Arizona, 85004

    Letticia Gillis, (520) 621-2061, lgillis@arizona.edu

    Sima Ehsani

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Staci Mellinger, RN, 503-215-1979, canrsrchstudies@providence.org

    Alison Conlin, MD, MPH

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Lindsey Gwaltney, masseyctbrst@vcu.edu

    Masey Ross, MD, MS

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20057

    Julie Castle, 202-687-2209, bickmorj@georgetown.edu

    Katia Khoury, MD

    Recruiting

  • University of Michigan Health-West

    Wyoming, Michigan, 49519

    Terminated

Other trials in United States

About this study

Official title: A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Read the detailed description

Collection of Correlative Samples at First Recurrence (Stage I consent) If feasible, optional correlative blood and fresh tissue will be collected during surgical excision of their 1st recurrence. Patients should then complete radiation therapy if that is indicated. Enrollment to the Treatment Phase will occur within 6 months of the last local treatment, surgery or radiation treatment, whichever occurred last.

Study Treatment (Stage II/ main consent)

Treatment includes:

  1. Ribociclib: Oral ribociclib at a dose of 400 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice.
  2. Physician's Choice Endocrine Therapy:

ET consists of one of the following:

  • Intramuscular fulvestrant
  • Oral anastrozole
  • Oral letrozole
  • Oral exemestane
  • Concomitant use with tamoxifen is not allowed.

Ribociclib administration is planned for 36 months and ET administration is planned for 60 months.

Being tested
Ribociclib, Fulvestrant, Anastrozole, Letrozole, Exemestane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibociclibDrug

    Also called Kisqali

    400 mg orally once daily Days 1-21 (28 day Cycle)

  • FulvestrantDrug

    Also called Faslodex

    500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+

  • AnastrozoleDrug

    Also called Arimidex

    1 mg orally once daily

  • LetrozoleDrug

    Also called Femara

    2.5 mg orally once daily

  • ExemestaneDrug

    Also called Aromasin

    25 mg orally once daily

Study groups in NCT05467891
Study groupRoleWhat they receive
Investigational GroupExperimentalThe drug ribociclib will be taken orally at a dose of 400 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice. All new subjects enrolled under the 08JUL2024 protocol or after will receive ribociclib 400mg daily for 21 days out of a 28-day cycle. Subjects receiving 600mg ribociclib under a prior protocol version will be switched to 400mg. Physician's choice of endocrine therapy includes: * 500 mg of fulvestrant received intramuscularly. This will be taken on Day 1 and Day 15 of Cycle 1 and on Day 1 of Cycle 2 and beyond. * 1 mg of anastrozole taken orally daily of the 28 day cycle. * 2.5 mg of letrozole taken orally daily of the 28 day cycle. * 25 mg of exemestane taken orally daily of the 28 day cycle. * Concomitant use with tamoxifen is not allowed. Premenopausal subjects must also be treated with ovarian suppression according to institutional standards or have undergone bilateral oophorectomy.
Receives: Drug: Ribociclib; Drug: Fulvestrant; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Free Survival (RFS)

    Estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant). RFS is defined as interval from registration until invasive or DCIS recurrence in the ipsilateral breast or locoregionally, invasive recurrence at a distant site, or death from breast cancer or any other cause, whichever occurs first. The censoring time is the completion of study at 6 years (3 years of patient accrual and 3 years of follow up time). The RFS at 3 years will be also treated as the primary endpoint in the power and sample size calculation.

    Measured: 3 years

Secondary outcomes (3)

  1. Distant Metastasis-Free Survival

    Estimate the Distant metastasis-free survival. Distant metastasis-free survival is defined as interval from registration to any recurrence or death from any cause.

    Measured: 3 years

  2. Overall Survival (OS)

    Estimate the OS. OS is defined as interval from registration to death from any cause.

    Measured: 3 years

  3. Assess adverse events

    Evaluate safety and tolerability of the study regimen. Safety will be evaluated by recording frequency and severity of adverse events; grading of toxicities will be done using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start13 Sep 2022
  3. Primary completion15 Aug 2028 (estimated)
  4. Study completion15 Aug 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467891
Sponsor's protocol ID
HCRN BRE20-468
Acronym
RaPhLRR
Status last verified
Jul 2026
First submitted
28 Jun 2022
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ribociclib, Fulvestrant and Anastrozole in people with Locoregional Recurrence and Hormone Receptor-positive Breast Cancer, run by Oana Danciu at 21 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 38 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oana Danciu, MD (312-996-1581, ocdanciu@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival (RFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05467891.

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 16 Jul 2026.

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