Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT04990921
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Palliative Radiation and Pembrolizumab — COMBINATION_PRODUCT
    Stereotactic radiation therapy will be administered as clinically indicated.

Study Details

This is a phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) in combination with pembrolizumab following disease progression after two prior lines of standard therapy in unresectable metastatic stage IV breast cancer

Key Dates

Start date
Sep 2, 2021
Status verified
May 2024
Primary completion
Jul 1, 2031
Completion
Jul 1, 2031

Study Design

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

Arms

  • Experimental: Palliative Radiation in Combination with Pembrolizumab
    Stereotactic radiation therapy will be delivered using either linac-based SBRT using 10x flattening filter-free (FFF) photons or Cyberknife Pencil Beam Technology utilizing 6X photons. Treatment will be delivered in 1-5 fractions. Fractionation and total dose (1500 - 3000 cGy) will depend on the site of disease, previous radiation treatment, and patient symptomatology. Pembrolizumab is supplied as pembrolizumab 100 mg/4 mL vials (25 mg/mL) solution for intravenous infusion. Pembrolizumab at a dose of 200 mg will be administered intravenously every 3 weeks (± 3 days).

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 3.0 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James Graham Brown Cancer CenterLouisvilleKentucky40202-

Find similar trials in Louisville, KY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
James Graham Brown Cancer Center· Louisville, KY

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