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Breast CancerPhase 1NCT05996107

Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

A Phase 1 study testing Ribociclib and Postoperative Radiation Therapy in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this research study is to determine the safety, tolerability and dose of Ribociclib when combined with adjuvant radiation in women with high-risk ER+ breast cancer. 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?
Ribociclib and Postoperative Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesUnited States
Study dates
27 Feb 2024to Feb 2030
Phase
Phase 1
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ER and/or PR-positive (≥ 1% positivity as determined by local pathology laboratory), HER2-negative breast cancer with > 3 lymph nodes involved on sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) OR have between 1-3 lymph nodes involved AND have T3 disease OR have between 1-3 lymph nodes involved and grade 3 breast cancer.
  • Age ≥ 18
  • Patients must have undergone gross total excision of all locoregional disease with negative margins (i.e. no tumor on ink). At least 21 days must elapse between surgical treatment for breast cancer and initiation of study treatment.
  • Patients must have completed chemotherapy (either in neoadjuvant or adjuvant setting). If received adjuvant chemotherapy, chemotherapy must have completed at least 21 days prior to initiation of study treatment.
  • Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and surgical side effects following definitive breast surgery except for neuropathy and alopecia
  • Adequate baseline hematologic, hepatic and renal function as indicated below:
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  • Patient has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by central laboratory for eligibility):
  • Absolute neutrophil count ≥ 1.5 × 109/L
  • Platelets ≥ 100 × 109/L
  • Hemoglobin ≥ 9.0 g/dL
  • INR ≤1.5 (unless the patient 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)
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula
  • Total bilirubin < 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 transaminase (AST) < 2.5 × ULN, except for patients with liver metastasis, who are only included if the AST is < 5 × ULN
  • Alanine transaminase (ALT) < 2.5 × ULN, except for patients with liver metastasis, who are only included if the ALT is < 5 × ULN
  • Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements before the first dose of study medication:
  • Potassium
  • Magnesium
  • Total Calcium (corrected for serum albumin)
  • QTcF interval at screening EKG ≤ 450ms (QT interval using Fridericia's correction).
  • Mean resting heart rate 50-90 bpm (determined from the EKG).
  • Ability to swallow study drug (Ribociclib).
  • ECOG Performance Status 0-1 (Karnofsky > 60%).
  • Availability of archival tumor tissue from surgical specimen.
  • Ability to understand and willingness to sign informed consent.
  • Women of childbearing potential must have confirmed negative pregnancy test (urine or serum) within 14 days of initiation of study treatment.

Who cannot join

  • Prior history of radiation therapy to the chest wall and/or regional nodes is not allowed (but prior radiation therapy to other sites is permissible).
  • Prior history of CDK4/6 inhibitor therapy.
  • Patients who are pregnant or breastfeeding.
  • Because radiation is known to be teratogenic, women of childbearing potential must have a documented negative pregnancy test performed prior to the start of study therapy (as above) and agree to use adequate contraception (hormonal or double barrier method of birth control; vasectomized partner; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Patient with distant metastases of breast cancer beyond regional lymph nodes and/or evidence of breast cancer recurrence prior to study enrollment.
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
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  • History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within 6 months prior to trial entry.
  • Documented cardiomyopathy.
  • Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) (testing not mandatory)
  • 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 Pointes (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 TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting trial treatment).
  • Inability to determine the QTcF interval.
  • Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block).
  • Uncontrolled arterial hypertension with systolic blood pressure > 160 mmHg.
  • 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 trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years. Questions regarding inclusion of individual subjects should be directed to Drs. Cobain and Speers (ecobain@med.umich.edu and cspeers@med.umich.edu).
  • Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization. Note: Patients with adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ are eligible.
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).
  • Patients must not receive any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy.
  • Patient is currently receiving any of the following substances within 7 days before randomization:
  • Concomitant medications, herbal supplements, and/or fruits (e.g. grapefruit, pummellos, starfruit, Seville oranges) and their juices that are known as strong inhibitors or inducers of CYP3A4/5.
  • Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • UHCMC Seidman Cancer Center

    Cleveland, Ohio, 44106

  • University of Michigan Health West

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase 1B Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

The purpose of this research study is to determine the safety, tolerability and dose of Ribociclib when combined with adjuvant radiation in women with high-risk ER+ breast cancer.

Once enrolled on study, patients will begin treatment with Ribociclib 400 mg daily at the same time as they initiate standard of care adjuvant radiation therapy- 50 Gy in 25 fractions or 42.56 Gy in 16 fractions +/- 10 Gy boost including comprehensive nodal. Paitents will continue treatment with Ribociclib for up to 6 weeks.

Conditions
Breast Cancer
Being tested
Ribociclib, Postoperative Radiation Therapy
Keywords
HR+/HER2-, Node positive, High-Risk breast cancer
Medical subject headings
Breast Neoplasms

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 daily with a possibly dose reduction to 200 mg daily if required

  • Postoperative Radiation TherapyRadiation

    50 Gy in 25 fractions or 42.56 Gy in 16 fraction +/- 10 Gy boost including comprehensive nodal

Study groups in NCT05996107
Study groupRoleWhat they receive
RT + RibociclibExperimentalAll patients will be treated with Ribociclib and standard of care radiation therapy
Receives: Drug: Ribociclib; Radiation: Postoperative Radiation Therapy

What is being measured

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

  1. Dose limiting toxicity (DLT) of ribociclib administered concurrently with adjuvant RT 1 month post last RT dose

    Safety evaluations will be based on the incidence, intensity, and type of adverse events, and clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. Safety variables will be tabulated and presented for all patients in the study. Exposure to study drug and reasons for discontinuation of study treatment will be tabulated.

    Measured: up through 30 days after the last dose of study drug or radiotherapy

Secondary outcomes (5)

  1. Cumulative incidence of local failure (i.e. local recurrence events)

    Calculation of follow-up time for all endpoints for patients will begin from the date of diagnosis until documentation of local or regional recurrence for local control, any failure (local, regional, or distant) or death for recurrence-free survival, and death for overall survival.

    Measured: up through 2 years after completion of protocol therapy

  2. Local failure-free survival

    The time from diagnosis date to the first of local or regional recurrence or death. Patients who are alive and free of local regional recurrence at lat follow up will be cencored at that date.

    Measured: up through 2 years after completion of protocol therapy

  3. Recurrence-free survival

    Date of diagnosis until documentation of death. Time-dependent and will be summarized using the Kaplan-Meier method or cumulative incidence method when competing events.

    Measured: up through 2 years after completion of protocol therapy

  4. Overall survival

    Overall survival as determined by the date of diagnosis until documentation of death. Time-dependent and will be summarized using the Kaplan-Meier method or cumulative incidence method when competing events.

    Measured: up through 2 years after completion of protocol therapy

  5. Disease free survival

    Defined as the time to the first of local, regional, or distant recurrence or death

    Measured: up through 2 years after completion of protocol therapy

Timeline

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

  1. First posted16 Aug 2023
  2. Study start27 Feb 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2030 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996107
Sponsor's protocol ID
UMCC 2022.071
Other IDs
HUM00231659
Status last verified
Oct 2026
First submitted
1 Aug 2023
Last updated
15 Oct 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 1 study testing Ribociclib and Postoperative Radiation Therapy in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 3 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 26 inclusion and 22 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

Dose limiting toxicity (DLT) of ribociclib administered concurrently with adjuvant RT 1 month post last RT dose (time frame: up through 30 days after the last dose of study drug or radiotherapy). 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 NCT05996107.

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 15 Oct 2026.

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