RECRUITING

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

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Conditions

Breast CancerPre-op radiationCDK4/6 inhibitorsPositive/HER2 negative (HR+/HER2-) breast cancerAbemaciclibCombination of abemaciclib and radiationPost-menopausal womenNode-negative hormone-receptor (HR) positive/ human epidermal growth factor receptor 2 (HER2)Negative breast cancersPhase 1bLetrozole and abemaciclib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer

Quick Facts

Study Start:2024-06-21
Study Completion:2032-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06139107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Expression of ER or progesterone receptors (PR)and negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting Protocol (CAP) guidelines
  3. * Oncotype diagnosis (DX) Breast Recurrence score of less than 25 on core biopsy specimen
  4. * Post-menopausal status defined:
  5. * 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.
  6. * No clinical suspicion of metastasis disease
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of follicle stimulating hormone (PFS) ≤2
  8. * Eligible to undergo surgery, either lumpectomy or mastectomy for local treatment of the breast cancer
  9. * Able to swallow oral medications
  10. * Adequate organ function for all of the following:
  11. * HR positive/HER2 -negative breast cancers are allowed as long as no other exclusions exist
  1. * History of ipsilateral breast cancer
  2. * Prior treatment with CDK4/6 inhibitors or aromatase inhibitors
  3. * History of chest wall or ipsilateral breast radiation
  4. * Inflammatory breast cancer
  5. * Needs neoadjuvant chemotherapy
  6. * Presence of distant metastatic disease
  7. * Contraindication for surgery
  8. * Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
  9. * 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
  10. * Life expectancy \< 12 weeks
  11. * History of allergy or hypersensitivity to any of the study drugs
  12. * Any significant medical condition, laboratory abnormality, or psychiatric illness
  13. * Serious and/or uncontrolled preexisting medical condition
  14. * Has had major surgery within 14 days prior to enrollment
  15. * 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
  16. * Has active systemic bacterial infection
  17. * 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

Contacts and Locations

Study Contact

Mridula A George, MD
CONTACT
732-235-9081
mridula@cinj.rutgers.edu
Mridula A George, MD
CONTACT
Mridula
mridula@cinj.rutgers.edu

Principal Investigator

Mridula A George, MD
PRINCIPAL_INVESTIGATOR
Cancer Institute of New Jersey Rutgers

Study Locations (Sites)

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States

Collaborators and Investigators

Sponsor: Mridula George, MD

  • Mridula A George, MD, PRINCIPAL_INVESTIGATOR, Cancer Institute of New Jersey Rutgers

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-21
Study Completion Date2032-09-30

Study Record Updates

Study Start Date2024-06-21
Study Completion Date2032-09-30

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Breast Cancer