A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06678269
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer
  • Breast Cancer Metastatic
  • Breast Cancer Stage IV
  • HER2 Negative Breast Carcinoma
  • HER2-negative Breast Cancer
  • Hormone-receptor-positive Breast Cancer
  • Metastatic Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

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

Interventions

  • Abemaciclib — DRUG
    The dose escalation portion of the study, a 3+3 design will be used. Once the MTD of Abemaciclib is reached, the phase Ib expansion portion will enroll up to 10 additional patients also requiring palliation to bone metastases
  • Radiation Therapy — RADIATION
    27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).

Study Details

The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.

Key Dates

Start date
Nov 15, 2024
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: Participants with HR+, HER2- metastatic breast cancer
    Participants will have a diagnosis of HR+, HER2- metastatic breast cancer. Abemaciclib, orally every 12 (± 2) hours beginning on the day of simulation thru the final day of radiotherapy for a maximum 28-day course. Radiation therapy, 27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation.

Primary Outcome Measure

Maximum tolerated dose/MTD of abemaciclib [ Time Frame: up to 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (All protocol activities)Basking RidgeNew Jersey07920
Lior Braunstein, MD
201-775-7446
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Lior Braunstein, MD
201-775-7446
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Lior Braunstein, MD
201-775-7446
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )CommackNew York11725
Lior Braunstein, MD
201-775-7446
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Lior Braunstein, MD
201-775-7446
Memorial Sloan Kettering Cancer Center (All protocol activites)New YorkNew York10065
Lior Braunstein, MD
201-775-7446
Memorial Sloan Kettering Nassau (All protocol activities)Rockville CentreNew York11553
Lior Braunstein, MD
201-775-7446

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering at Basking Ridge (All protocol activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (All Protocol Activities )· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All protocol activites)· New York, NY

Related Studies