Breast CancerPhase 1NCT06139107
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
A Phase 1 study testing Abemaciclib and Letrozole in people with Breast Cancer, run by Mridula George, MD at 4 sites in United States.
Trial summary
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Abemaciclib and Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Aug 2024to 30 Sep 2032
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed diagnosis of invasive (ductal, lobular or mixed histology), Clinically inapparent tumor that is not palpable. (cT1-T2N0)disease. Minimum tumor size of 1.5 cm
- Expression of ER or progesterone receptors (PR)and negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting Protocol (CAP) guidelines
- Oncotype diagnosis (DX) Breast Recurrence score of less than 25 on core biopsy specimen
- Post-menopausal status defined:
- age <60 with amenorrhea for at least 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and estradiol and FSH (follicle stimulating hormone) in postmenopausal range.
- No clinical suspicion of metastasis disease
Show all 12Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of follicle stimulating hormone (PFS) ≤2
- Eligible to undergo surgery, either lumpectomy or mastectomy for local treatment of the breast cancer
- Able to swallow oral medications
- Adequate organ function for all of the following:
- Absolute Neutrophil (ANC) >1.5 x 10/L Platelets >100 x 10/L Hemoglobin >8 g/dL - May receive erythrocyte transfusions to achieve this level Total Bilirubin <1.5 x Upper Limit of Normal (ULN) Alanine Aminotransferase (ATL) and Aspartate Aminotransferase (AST) <3 x ULN
- HR positive/HER2 -negative breast cancers are allowed as long as no other exclusions exist
Who cannot join
- History of ipsilateral breast cancer
- Prior treatment with CDK4/6 inhibitors or aromatase inhibitors
- History of chest wall or ipsilateral breast radiation
- Inflammatory breast cancer
- Needs neoadjuvant chemotherapy
- Presence of distant metastatic disease
Show all 17Show fewer
- Contraindication for surgery
- Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
- Life expectancy < 12 weeks
- History of allergy or hypersensitivity to any of the study drugs
- Any significant medical condition, laboratory abnormality, or psychiatric illness
- Serious and/or uncontrolled preexisting medical condition
- Has had major surgery within 14 days prior to enrollment
- Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently enrolled in any other type of medical research
- Has active systemic bacterial infection
- Personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, 07109
Mridula George, MD, 732-235-9809, mridula@cinj.rutgers.edu
Kassie DiOrio, 732-454-9795, kassie.diorio@rutgers.edu
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Mridula George, MD, 7322358909, mridula@cinj.rutgers.edu
Kassie DiOrio, 7324549795, kassie.diorio@rutgers.edu
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Mridula George, MD, 7322358909, mridula@cinj.rutgers.edu
Kassie DiOrio, 7324549795, kassie.diorio@rutgers.edu
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08873
Mridula George, MD, 732-235-8909, mridula@cinj.rutgers.edu
Kassie DiOrio, 7324549795, kassie.diorio@rutgers.edu
About this study
Official title: RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.
Read the detailed description
In this phase 1b study, researchers will conduct a comprehensive investigation into the concurrent administration of pre-operative radiation therapy and CDK4/6 inhibitors in a carefully selected participant population diagnosed with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to elucidate the safety and feasibility of this combination therapy. Participants will undergo rigorous evaluation and monitoring to assess the potential synergistic effects and adverse reactions resulting from the simultaneous use of radiation and CDK4/6 inhibitors. Detailed clinical assessments, imaging studies, and laboratory analyses will be performed to monitor treatment response and any associated side effects.
The study hypothesizes that this combination therapy will be well-tolerated, paving the way for further investigations into its efficacy. By closely examining the outcomes and tolerability of this treatment approach, researchers aim to contribute valuable data to the understanding of novel therapeutic strategies for HR+/HER2- breast cancer. The detailed analysis of participant responses and safety profiles in this study will provide crucial insights for optimizing future clinical interventions and improving outcomes for individuals diagnosed with this specific breast cancer subtype.
- Conditions
- Breast Cancer
- Being tested
- Abemaciclib, Letrozole
- Keywords
- Pre-op radiation, CDK4/6 inhibitors, Positive/HER2 negative (HR+/HER2-) breast cancer, Abemaciclib, Combination of abemaciclib and radiation, Post-menopausal women, Node-negative hormone-receptor (HR) positive/ human epidermal growth factor receptor 2 (HER2), Negative breast cancers, Phase 1b, Letrozole and abemaciclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called CDK4/6 Inhibitor Therapy.
150mg twice a day for 3 cycles prior to radiation.
LetrozoleDrug
Also called Aromatase Inhibitor Therapy.
Letrozole 2.5mg daily
| Study group | Role | What they receive |
|---|---|---|
| Combined Pre-Operative Therapy with Abemaciclib, Letrozole, and Radiation in HR+/HER2- Breast Cancer | Experimental | Part A:
* 28-day treatment cycle based on abemaciclib
* Abemaciclib 150mg BID (twice a day).
* Letrozole 2.5mg daily and Abemaciclib 150mg twice a day for three cycles prior to undergoing radiation therapy.
* On-treatment biopsy conducted between cycle 3, day 16, and cycle 4, day 1.
* This occurs two weeks prior to transitioning to Part B.
Dose Level 0 150mg Twice daily with at least 6 hours between doses Dose Level 1 100mg Twice daily with at least 6 hours between doses Dose Level 2 50mg Twice daily with at least 6 hours between doses
Part B:
* Continue treatment from Part A, 28-day cycle based on abemaciclib.
* Abemaciclib 150mg BID (twice a day) with letrozole 2.5mg daily.
* Part B focuses on the administration of radiation therapy following the three cycles of combined abemaciclib and letrozole.
* Targeted radiation treatment.
Part C:
* Two cycles of abemaciclib, 150mg twice a day.
* Letrozole 2.5mg daily.
Part D:
Surgery Receives: Drug: Abemaciclib; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)
The outcome measure aims to characterize the safety and toxicity profile of the study treatment by assessing the occurrence and severity of adverse events (AEs) as measured using the CTCAE v.5. The CTCAE v.5 utilizes a standardized grading scale to assess the severity of adverse events. The scale consists of grades ranging from 1 to 5, with each grade corresponding to a specific level of severity. The grades are:
Grade 1 Mild Event is asymptomatic or mild, requiring minimal or no medical intervention.
Grade 2 Moderate Event minimal to moderate interference with daily activities, and some medical intervention.
Grade 3 Severe Event causes significant interference with daily activities, and medical intervention or treatment is required.
Grade 4 Life-threatening or disabling Event poses immediate risk to life or function, requiring urgent medical intervention or treatment.
Grade 5 Death Event results in death related to the adverse event.
Measured: From baseline, every six months, to five years
Secondary outcomes (5)
Clinical efficacy of the study treatment regimen measured by Rates of Residual Cancer Burden (RCB).
Rate of post-operative complications will be measured by RCB. as defined below:
RCB-0: No residual cancer in the breast RCB-I: Minimal residual cancer (only small clusters or single cells) RCB-II: Moderate residual cancer (larger or more numerous groups of cells) RCB-III: Extensive residual cancer (large nests, sheets, or extensive involvement of breast tissue)
RCB Index Calculation:
The RCB index is calculated based on these components. Scores to each component (e.g., size, lymph node involvement, Ki67 index, invasive vs. in situ disease) and then determine the overall RCB index score for a participants.
Interpretation:
RCB-0: Pathologic complete response, indicating no visible cancer in the breast after treatment.
RCB-I, RCB-II, RCB-III: Increasing levels of residual cancer burden, with RCB-III representing the highest burden.
Measured: From baseline, every six months, to five years
Rate of post-operative complications measured by descriptive statistics
The utilization of descriptive statistics to present a comprehensive overview of the post-operative complications. This includes the calculation of means, medians, standard deviations, to understanding of the range and severity of complications observed in the participants cohort.
Measured: From baseline, every six months, to five years
Rate of breast-conserving surgery measured with with a 95% confidence interval for proportions
The evaluation of the Rate of Breast-Conserving Surgery, assessed as a proportion with a 95% confidence interval, provides an understanding of the prevalence of breast-conserving procedures within the studied population. This approach employs rigorous statistical analysis to calculate the proportion of participants who underwent breast-conserving surgery, accompanied by a confidence interval that enhances the reliability of the findings.
The calculated proportion signifies the fraction of participants opting for breast-conserving surgery among the total number of individuals included in the study. This proportion serves as a crucial metric, indicating the preference and acceptance of less invasive surgical methods among participants diagnosed with breast cancer. The confidence interval serves as a measure of the precision and reliability of the calculated proportion.
Measured: From baseline, every six months, to five years
Rates of residual cancer burden (RCB) as a proportion with 95% confidence interval
The analysis of Rates of Residual Cancer Burden as a proportion, accompanied by a 95% confidence interval, offers a precise and reliable understanding of the residual cancer burden within the studied population. This approach involves calculating the proportion of participants with different levels of residual cancer burden (such as RCB-0, RCB-I, RCB-II, RCB-III) among the total number of participants evaluated. The 95% confidence interval provides a range in which the true proportion of participants with each level of residual cancer burden is likely to fall, enhancing the statistical precision and reliability of the findings.
Measured: From baseline, every six months, to five years
Two year invasive disease-free survival (DFS) rate
DFS rate is calculated by dividing the number of participants who have not experienced disease recurrence or progression within a specified timeframe by the total number of participants enrolled in the clinical trial.
DFS Rate (%) = (Number of participants with no disease recurrence or progression / Total number of participants enrolled) × 100 A higher DFS rate indicates a greater efficacy of liposomal doxorubicin and carboplatin as an adjuvant treatment, suggesting their ability to delay or prevent disease recurrence or progression in participants. A higher DFS rate implies a better prognosis and improved disease control in the adjuvant setting.
Kaplan-Meier survival curve will be calculated and the rate and 95% confidence interval for disease-free survival calculated.
Measured: From baseline, every six months, to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 Aug 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mridula George, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mridula George, MD, Rutgers, The State University of New Jersey
- Investigators
- Mridula A George, MD, Principal investigator, Cancer Institute of New Jersey Rutgers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139107
- Sponsor's protocol ID
- 042311
- Other IDs
- Pro2023001900
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2023
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT06139107
- Acronym / sponsor ID
- 042311
- Conditions
- Breast Cancer
- Keywords
- Pre-op radiation, CDK4/6 inhibitors, Positive/HER2 negative (HR+/HER2-) breast cancer, Abemaciclib, Combination of abemaciclib and radiation, Post-menopausal women, Node-negative hormone-receptor (HR) positive/ human epidermal growth factor receptor 2 (HER2), Negative breast cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mridula George, MDUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.
Detailed description
In this phase 1b study, researchers will conduct a comprehensive investigation into the concurrent administration of pre-operative radiation therapy and CDK4/6 inhibitors in a carefully selected participant population diagnosed with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to elucidate the safety and feasibility of this combination therapy. Participants will undergo rigorous evaluation and monitoring to assess the potential synergistic effects and adverse reactions resulting from the simultaneous use of radiation and CDK4/6 inhibitors. Detailed clinical assessments, imaging studies, and laboratory analyses will be performed to monitor treatment response and any associated side effects.
The study hypothesizes that this combination therapy will be well-tolerated, paving the way for further investigations into its efficacy. By closely examining the outcomes and tolerability of this treatment approach, researchers aim to contribute valuable data to the understanding of novel therapeutic strategies for HR+/HER2- breast cancer. The detailed analysis of participant responses and safety profiles in this study will provide crucial insights for optimizing future clinical interventions and improving outcomes for individuals diagnosed with this specific breast cancer subtype.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Pre-Operative Therapy with Abemaciclib, Letrozole, and Radiation in HR+/HER2- Breast Cancer | Experimental | Drug: Abemaciclib, Drug: LetrozolePart A: * 28-day treatment cycle based on abemaciclib * Abemaciclib 150mg BID (twice a day). * Letrozole 2.5mg daily and Abemaciclib 150mg twice a day for three cycles prior to undergoing radiation therapy. * On-treatment biopsy conducted between cycle 3, day 16, and cycle 4, day 1. * This occurs two weeks prior to transitioning to Part B. Dose Level 0 150mg Twice daily with at least 6 hours between doses Dose Level 1 100mg Twice daily with at least 6 hours between doses Dose Level 2 50mg Twice daily with at least 6 hours between doses Part B: * Continue treatment from Part A, 28-day cycle based on abemaciclib. * Abemaciclib 150mg BID (twice a day) with letrozole 2.5mg daily. * Part B focuses on the administration of radiation therapy following the three cycles of combined abemaciclib and letrozole. * Targeted radiation treatment. Part C: * Two cycles of abemaciclib, 150mg twice a day. * Letrozole 2.5mg daily. Part D: Surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically and/or cytologically confirmed diagnosis of invasive (ductal, lobular or mixed histology), Clinically inapparent tumor that is not palpable. (cT1-T2N0)disease. Minimum tumor size of 1.5 cm
- Expression of ER or progesterone receptors (PR)and negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting Protocol (CAP) guidelines
- Oncotype diagnosis (DX) Breast Recurrence score of less than 25 on core biopsy specimen
- Post-menopausal status defined:
- age <60 with amenorrhea for at least 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and estradiol and FSH (follicle stimulating hormone) in postmenopausal range.
Key exclusion criteria (17 listed)
- History of ipsilateral breast cancer
- Prior treatment with CDK4/6 inhibitors or aromatase inhibitors
- History of chest wall or ipsilateral breast radiation
- Inflammatory breast cancer
- Needs neoadjuvant chemotherapy
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 |
|---|---|---|
| AbemaciclibAlso: CDK4/6 Inhibitor Therapy.150mg twice a day for 3 cycles prior to radiation. | Drug | Combined Pre-Operative Therapy with Abemaciclib, Letrozole, and Radiation in HR+/HER2- Breast Cancer |
| LetrozoleAlso: Aromatase Inhibitor Therapy.Letrozole 2.5mg daily | Drug | Combined Pre-Operative Therapy with Abemaciclib, Letrozole, and Radiation in HR+/HER2- Breast Cancer |
Primary outcome
Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Time frame: From baseline, every six months, to five years
The outcome measure aims to characterize the safety and toxicity profile of the study treatment by assessing the occurrence and severity of adverse events (AEs) as measured using the CTCAE v.5. The CTCAE v.5 utilizes a standardized grading scale to assess the severity of adverse events. The scale consists of grades ranging from 1 to 5, with each grade corresponding to a specific level of severity. The grades are: Grade 1 Mild Event is asymptomatic or mild, requiring minimal or no medical intervention. Grade 2 Moderate Event minimal to moderate interference with daily activities, and some medical intervention. Grade 3 Severe Event causes significant interference with daily activities, and medical intervention or treatment is required. Grade 4 Life-threatening or disabling Event poses immediate risk to life or function, requiring urgent medical intervention or treatment. Grade 5 Death Event results in death related to the adverse event.
5 secondary outcomes
Clinical efficacy of the study treatment regimen measured by Rates of Residual Cancer Burden (RCB).
Time frame: From baseline, every six months, to five years
Rate of post-operative complications measured by descriptive statistics
Time frame: From baseline, every six months, to five years
Rate of breast-conserving surgery measured with with a 95% confidence interval for proportions
Time frame: From baseline, every six months, to five years
Rates of residual cancer burden (RCB) as a proportion with 95% confidence interval
Time frame: From baseline, every six months, to five years
Two year invasive disease-free survival (DFS) rate
Time frame: From baseline, every six months, to five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- 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.
Mridula A George, MD principal investigator
Cancer Institute of New Jersey Rutgers
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abemaciclib and Letrozole in people with Breast Cancer, run by Mridula George, MD at 4 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 12 inclusion and 17 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 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Contact Mridula A George, MD (732-235-9081, mridula@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0) (time frame: From baseline, every six months, to five years). 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 14 Nov 2025.