Metastases Directed Therapy for Oligometastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorNational Cancer Institute, Egypt
About this trial
This is a phase III randomized study evaluating the benefit from adding metastases directed therapy and locoregional treatment of the primary in breast cancer patients diagnosed with de novo oligometastatic disease patients will be randomized to receive the standard of care (SOC) treatment vs. systemic treatment + Stereotactic Ablative Radiation Therapy. Responders will be randomized to either undergo loco-regional management of the primary tumor or not
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 to 70 years.
Pathological evidence of breast cancer, any grade, any T stage.
Radiological (at least) evidence of metastatic activity with maximum number of 5 extracranial lesions.
Performance status ≤ 2
Disqualifiers
Prior radiotherapy to affected site(s) in less than a year.
Active Connective tissue diseases (e.g Rheumatoid Arthritis).
Progression to widespread metastatic disease
Cases with brain metastasis
Trial design
Design model
Factorial
Treatments tested in this trial
Stereotactic Ablative Radiation Therapy
RadiationSABR to all metastatic lesions
Locoregional treatment
Procedure/Surgerymastectomy or BCS for the primary tumor
Standard of Care
Other interventionSystemic treatment and palliative treatment
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Standard of CareActive comparator 1 intervention
Group B: Metastases Directed TherapyExperimental treatment 1 intervention
Group C: Locoregional Treatment of the PrimaryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival
Time till disease progression
Time frame
from the time of randomization till disease progression or death up-to 120 months2
Overall Response rate
rate of patients responding to therapy
Time frame
assessed using physical exam and PET CT after six months of systemic treatmentSponsors and contacts
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Source ClinicalTrials.gov