Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer
NCT04990921 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-02-20
Summary
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
Conditions
Interventions
- COMBINATION_PRODUCT
-
Palliative Radiation and Pembrolizumab
Stereotactic radiation therapy will be administered as clinically indicated.
Sponsors & Collaborators
-
James Graham Brown Cancer Center
collaborator OTHER -
University of Louisville
lead OTHER
Principal Investigators
-
Elizabeth Riley, MD · UL Health Brown Cancer Center Deputy Director, Health Affairs
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-02
- Primary Completion
- 2031-07-01
- Completion
- 2031-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
NCT00527293 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)
NCT04917640 ·Status: WITHDRAWN
-
Accelerated Partial Breast Irradiation With 3D-CRT and IMRT
NCT02003560 ·Status: UNKNOWN ·Phase: PHASE2
-
Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
NCT00647582 ·Status: COMPLETED ·Phase: PHASE2
-
Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
NCT01245712 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Ultrahypofractionated Whole Breast Radiation Following Chemotherapy
NCT06664892 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer
NCT00602108 ·Status: COMPLETED ·Phase: PHASE2
-
Photobiomodulation for Breast Cancer Radiodermatitis
NCT04059809 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Proton Therapy for Early Stage Breast Cancer
NCT00614172 ·Status: COMPLETED ·Phase: NA
-
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
NCT02927912 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
NCT00005587 ·Status: COMPLETED ·Phase: PHASE3
-
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
NCT00005588 ·Status: COMPLETED ·Phase: PHASE3
-
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
NCT01082211 ·Status: COMPLETED ·Phase: PHASE2
-
Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
NCT00002851 ·Status: UNKNOWN ·Phase: PHASE3
-
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
NCT00599989 ·Status: COMPLETED ·Phase: NA
-
Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer
NCT02186470 ·Status: COMPLETED ·Phase: NA
-
3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer
NCT00802711 ·Status: TERMINATED ·Phase: NA
-
Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
NCT01215162 ·Status: COMPLETED ·Phase: PHASE2
-
3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
NCT00068263 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Accelerated Partial Breast Irradiation for Early Breast Cancer
NCT00418210 ·Status: COMPLETED ·Phase: NA
-
Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
NCT00929214 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
NCT04959474 ·Status: RECRUITING ·Phase: NA
-
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy
NCT04535895 ·Status: WITHDRAWN ·Phase: NA
-
Pre- Versus Postoperative Accelerated Partial Breast Irradiation
NCT02913729 ·Status: TERMINATED ·Phase: NA
-
Prospective Study on Exemption of Tumor Bed Boost Radiotherapy for pCR Patients After Breast Conserving Surgery With Neoadjuvant Therapy
NCT07113613 ·Status: RECRUITING ·Phase: PHASE2