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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT05996107
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    400 mg daily with a possibly dose reduction to 200 mg daily if required
  • Postoperative Radiation Therapy — RADIATION
    50 Gy in 25 fractions or 42.56 Gy in 16 fraction +/- 10 Gy boost including comprehensive nodal

Study Details

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.

Key Dates

Start date
Feb 27, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RT + Ribociclib
    All patients will be treated with Ribociclib and standard of care radiation therapy

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Cancer Cancer Answer Line
[email protected]
800-865-1125
Jody Sharp, BS
[email protected]
734-615-4909
University of Michigan Health WestWyomingMichigan49519
Clinical Research Group
[email protected]
616-252-5127
Chester Wilson, MD (PRINCIPAL_INVESTIGATOR)
UHCMC Seidman Cancer CenterClevelandOhio44106
Lisa Edgehouse
[email protected]
216-844-8304
Janice Lyons, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Michigan· Ann Arbor, MIUniversity of Michigan Health West· Wyoming, MIUHCMC Seidman Cancer Center· Cleveland, OH

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