Trials / Completed

CompletedNCT02364557

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

A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

Status: Completed
Phase: Phase 2 / Phase 3
Study type: Interventional
Enrollment: 129 (actual)

Sponsor: NRG Oncology · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Phase II: To determine whether ablation \[through stereotactic body radiation therapy (SBRT) (stereotactic radiosurgery) and/or surgical resection of all known metastases\] in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. II. Phase III: To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). SECONDARY OBJECTIVES: I. To evaluate treated metastasis control according to tumor receptor status \[estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2)\], use of chemotherapy, surgery versus (vs.) ablative therapy, and number of metastases. II. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and number of metastases. III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy compared with those treated with standard medical therapy alone. EXPLORATORY OBJECTIVE: I. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery. TRANSLATIONAL RESEARCH OBJECTIVES: I. To determine whether \< 5 circulating tumor cells (CTCs) (per 7.5 ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer. II. To determine whether \< 5 CTCs (per 7.5 ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer. III. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS. IV. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS. V. To store material for retrospective analysis of circulating tumor deoxyribonucleic acid (ctDNA). VI. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2014-12-24
Primary completion: 2021-12-20
Completion: 2025-09-04
First posted: 2015-02-18
Last updated: 2025-10-15
Results posted: 2023-02-08

Locations

165 sites across 4 countries: United States, Canada, Saudi Arabia, South Korea

Source: ClinicalTrials.gov record NCT02364557. Inclusion in this directory is not an endorsement.