RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

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.

Trial Details

NCT ID

NCT06139107

Phase

PHASE1

Sponsor

Mridula George, MD

Status

RECRUITING

Cancer Type

HER2 Negative Breast Cancer

Interventions

Abemaciclib
Letrozole

Locations (sample)

Belleville, New Jersey, United States|40.79371,-74.15014
Livingston, New Jersey, United States|40.79593,-74.31487
New Brunswick, New Jersey, United States|40.48622,-74.45182
Somerville, New Jersey, United States|40.57427,-74.60988

Key Eligibility Criteria

Histologically and/or cytologically confirmed diagnosis of invasive (ductal, lobular or mixed histology), Clinically inapparent tumor that is not p…
Expression of ER or progesterone receptors (PR)and negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting Pr…
Oncotype diagnosis (DX) Breast Recurrence score of less than 25 on core biopsy specimen
Post-menopausal status defined:

For full eligibility, visit ClinicalTrials.gov.

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