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Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival

NCT02364557 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-05-19

Study results available
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Summary

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Conditions

  • Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
  • Metastatic Breast Carcinoma
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Malignant Neoplasm in the Liver
  • Metastatic Malignant Neoplasm in the Lung
  • Metastatic Malignant Neoplasm in the Lymph Nodes
  • Metastatic Malignant Neoplasm in the Spine
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8

Interventions

RADIATION

Stereotactic Body Radiotherapy

Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy.

PROCEDURE

Surgery

All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Steven J Chmura · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-24
Primary Completion
2021-12-20
Completion
2025-09-04

Countries

  • United States
  • Canada
  • Saudi Arabia
  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364557 on ClinicalTrials.gov