Phase 3
N=129
Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival
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
Bottom Line
View on ClinicalTrials.gov: NCT02364557 ↗Enrolled (actual)
129
Serious AEs
5.9%
Results posted
Feb 2023
Primary outcome: Primary: Progression-free Survival (Phase II) — 23.0; 19.5 months — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Stereotactic Body Radiotherapy (Radiation); Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NRG Oncology
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (Phase II) |
23.0; 19.5 | 0.36 |
| PRIMARY Overall Survival (Phase III) |
— | — |
| SECONDARY Percentage of Participants With Treated Metastasis Progression on the SOC + Ablation Arm |
45.0 | — |
| SECONDARY Percentage of Participants With New Metastases |
47.7; 49.6 | 0.91 |
| SECONDARY Number of Patients by Highest Grade Adverse Event Reported |
7; 15; 32; 26; 12; 11 | — |
| SECONDARY Progression-free Survival in the Presence or Absence of Circulating Tumor Cells (CTCs) |
42.3; 42.3 | 0.90 |
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.
Eligibility Criteria
Inclusion Criteria
- A patient cannot be considered eligible for this study unless all of the following conditions are met.
- Pathologically confirmed metastatic breast cancer
- Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis;
- Note: estrogen, progesterone and HER2 status of metastasis preferred for stratification
- Number of allowable metastases:
- = = 500 cells/mm^3
- Platelets >= 50,000 cells/mm^3
- Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
- For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria
- Patients with any of the following conditions are NOT eligible for this study.
- Pathologic evidence of active primary disease or local/regional breast tumor recurrence at the time of registration;
- Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported
- Metastases with indistinct borders making targeting not feasible
- Note: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required
- Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals)
- Metastases located within 3 cm of the previously irradiated structures:
- Spinal cord previously irradiated to > 40 Gy (delivered in = 50 Gy (delivered in = 45 Gy (delivered in = 50 Gy (delivered in = 30% (delivered in = = 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
Data sourced from ClinicalTrials.gov (NCT02364557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.