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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
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
California - Northern
NRG Oncology
 
Acronym NCT No.
NCT02364557
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
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. 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. (Phase II-R) II. To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). (Phase III) SECONDARY OBJECTIVES: I. To evaluate treated metastasis control according to tumor receptor status (estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2), use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis (may expand to >= 2 to =< 4 following completion of a Phase I trial). 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 solitary metastasis vs. 2 metastases (may expand to >= 2 to =< 4 following completion of the Phase I NRG-BR001 trial). III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy alone. IV. 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.
 
 
 
Inclusion Criteria
  • 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
  • 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)
  • 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
  • Zubrod performance status =< 2 within 30 days prior to registration Absolute neutrophil count (ANC) >= 500 cells/mm
  • 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
  • Please contact study team for additional criteria
 
Exclusion Criteria
  • 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
  • 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
  • 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
  • Please contact study team for additional exclusion criteria
 
Keywords and/or Specific Medical Conditions
  • Breast Diseases
  • Respiratory Tract Diseases
  • Breast Neoplasms
  • Signs and Symptoms, Digestive
  • Dyspnea
  • Signs and Symptoms, Respiratory
  • Neoplasms
  • Skin Diseases
  • Neoplasms by Site
  • Vomiting
  • NRG-BR002
  • Oncology (Adult)
  • Respiration Disorders
 
KP Clinical Facility
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Antioch
  • Diablo Medical Center-Deer Valley
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Fresno Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Richmond Medical Center
  • Roseville Medical Center
  • Roseville Medical Center-Rancho Cordova
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward, MD
Contact Information:
- CTP Team
-ctpcollaborate@kp.org
-Vallejo Medical Center


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