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NCT05996107 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer, sponsored by University of Michigan Rogel Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
3
Study locations

NCT05996107 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT05996107, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
3
Study locations

Study 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. 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 Studied

Breast Cancer

Interventions

  • DRUG Ribociclib
  • RADIATION Postoperative Radiation Therapy

Study Locations (3)

Michigan

  • University of Michigan - Ann Arbor
  • University of Michigan Health West - Wyoming

Ohio

  • UHCMC Seidman Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-02-27
Est. Completion 2030-06
Phase Phase 1

Sponsor

University of Michigan Rogel Cancer Center

292 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05996107

The ClinicalTrials.gov registry entry for NCT05996107 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ribociclib is the first listed.

NCT05996107 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Ohio.

Frequently Asked Questions

What is clinical trial NCT05996107 about?

NCT05996107 is a clinical study titled "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 st...

What is the current status of trial NCT05996107?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-02-27. Estimated completion is 2030-06.

What conditions does trial NCT05996107 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05996107?

The interventions under investigation include: Ribociclib (DRUG), Postoperative Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT05996107?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05996107 being conducted?

This trial has 3 study locations across Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.