NCI Community Oncology Research Program - Protocol Summary
NRG-BR002 - "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"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Breast Clinical Trial
CANCER TYPE: Stage IV
RESEARCH BASE: NRG
NCT NUMBER: NCT02364557
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 09/05/2018 (19:15:10)
Stage IV, breast ca, 1-4 metastases, standard of care systemic therapy vs. standard of care systemic therapy + SBRT or surgical ablation of all metastases
IGRT is required for this study. Either 3DCRT or IMRT (including VMAT) are acceptable planning techniques.
Digital RT data will be submitted to NRG via TRIAD.
Treatment (Supplied drug: none)
Continue current standard of care systemic therapy, and any paliative therapy consistent with best medical practice (radiotherapy, surgery, etc.)
Continue current standard of care systemic therapy + SBRT or surgery for all metastases
SBRT must begin begin within 6 weeks of registration, and be completed within 3 weeks of first dose of SBRT.
Surgery must occur within 6 weeks of registration.
- Pathologically confirmed metastatic breast cancer
- Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
- Number of allowable metastases:
- ≤ 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:
- peripheral lung
- osseous (bone)
- central lung
- abdominal–pelvic(lymph node/adrenal gland
- mediastinal/cervical lymph node
- All known disease amenable to metastasis-directed therapy with either SBRT or resection
- Symptomatic bone metastasis are allowed if ablative therapy can be delivered.
- Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites.
- Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy.
- Maximum diameter of individual metastasis in any dimension ≤ 5 cm
- There are no restrictions on distance between the metastases.
- For patients who have ONLY peripheral lung, osseous spinal abdominal-pelvic, and/or central lung metastasis, there are no restrictions on distance between the metastases.
- For patients with any other combination of the seven allowable metastatic sites, metastases must be >5 cm away from each other (defined as Edge to Edge of tumor).
NOTE: If metastases are ≤5 cm away from each other, consider enrollment in NRG-BR001
- Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis. First-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2 or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given. If given before study entry, it cannot have exceeded a duration of 12 months at the time of registration. (Note: Sequencing of ablative therapy (surgery or SBRT) relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician.)
- The primary tumor site must be controlled prior to registration
- For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration.
- The definition of control is definitive surgery (+/- radiotherapy) for the primary tumor.
- Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 60 days prior to registration;
- Clinical grade CT scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body PET/CT within 60 days prior to study registration
- Age ≥ 18
- Zubrod Performance Status ≤ 2 within 60 days prior to registration
- CBC/differential obtained within 60 days prior to registration on study, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 500 cells/mm3;
- Platelets ≥ 50,000 cells/mm3;
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve 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;
- Patient must be female
- No pathologic evidence of local/regional breast tumor recurrence;
- No 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
- No 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 HU. Therefore, we acknowledge that such determinations will pose a challenge and thus the physician’s judgment will be required;
- No prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals);
- No metastases located within 3 cm of the previously irradiated structures:
- Spinal cord previously irradiated to > 40 Gy (delivered in ≤ 3 Gy/fraction)
- Brachial plexus previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
- Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in ≤ 3 Gy/fraction)
- Brainstem previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
- Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction)
- Primary tumor irradiated with SBRT
- Metastasis irradiated with SBRT
- No brain metastases;
- No exudative, bloody, or cytological proven malignant effusions;
- No severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- No pregnancy. Lactating females must cease expression of milk prior to signing consent to be eligible.
- No HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.