Titre 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
Protocole ID NRG-BR002
ClinicalTrials.gov ID NCT02364557
Type(s) de cancer Sein
Phase Phase III
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dre Laura Masucci
Coordonnateur(trice) Diane Trudel
514-890-8000 poste 11181
Statut Actif en recrutement
Date d'activation 04-02-2016
Critètes d'éligibilité
  • Pathologically confirmed metastatic breast cancer within 270 days prior to registration
  • Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
  • =< 2 metastases seen on standard imaging within 30 days prior to registration
  • Controlled primary tumor site defined as >= 3 months (90 days) recurrence-free interval since completion of definitive surgical management
  • All known disease amenable to metastasis-directed therapy with either SBRT or resection
  • NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
  • NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
  • NOTE: 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
  • 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
  • First-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2 or other standard targeted therapy) for metastatic breast cancer not to have exceeded a duration of 6 months at the time of registration
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 30 days prior to registration
  • Computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 30 days prior to study registration
  • Zubrod performance status =< 2 within 30 days prior to registration
  • Absolute neutrophil count (ANC) >= 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 must provide study-specific informed consent prior to study entry
Critètes d'exclusion
  • Pathologic evidence of local/regional breast tumor recurrence
  • Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years
  • 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
  • Metastases located within 3 cm of the previously irradiated structures:
  • Spinal cord previously irradiated to > 40 Gy
  • Brachial plexus previously irradiated to > 50 Gy
  • Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
  • Brainstem previously irradiated to > 50 Gy
  • Lung previously irradiated with prior V20Gy > 30%
  • Brain metastases
  • Exudative, bloody, or cytological proven malignant effusions
  • 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
  • Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible
  • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 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