Ribociclib and Endocrine Treatment for Recurrent Breast Cancer
This study is looking at how well ribociclib (a drug) works when combined with a doctor's choice of endocrine therapy (hormone treatment) for people whose breast cancer has returned in the same area (locoregional recurrence). This is for breast cancer that is hormone receptor-positive (meaning hormones help it grow) and HER2-negative (a specific protein is not overproduced). You could be eligible if you are 18 or older and have this type of breast cancer. The main goal is to see how long people live without the cancer coming back (recurrence-free survival) after 3 years. The study plans to enroll 200 participants, but its current status is unclear.
- Study design
- This is an open-label, single-arm study, meaning all participants receive the study treatment and everyone knows what treatment is being given. It plans to include 200 participants.
- What's involved
- You would take ribociclib daily for 21 days out of a 28-day cycle for 36 months, along with an endocrine therapy chosen by your doctor for 60 months. Optional blood and tissue samples may be collected at the time of your first recurrence.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, recurrence-free survival, is measured at 3 years after treatment begins.
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NCT05467891
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentOana DanciuInvestigator-initiated
~200 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:RibociclibFulvestrantAnastrozoleLetrozoleExemestane
At a glance
Recruiting sites
19 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence Free Survival (RFS)
Measured over 3 years
Conditions
Where it's being run
21 sites across 19 statesMichigan2
Virginia2
Alabama1
Arizona1
District of Columbia1
Florida1
Illinois1
Indiana1
Study leadership
- Oana Danciu, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
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.
Exclusion
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.
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.
What this trial measures
- Recurrence Free Survival (RFS)3 years
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.