Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstituto do Cancer do Estado de São Paulo
About this trial
Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.
Eligibility criteria
Qualifiers
Female sex
≥ 18 years of age
Histologically confirmed invasive breast cancer, with oligometastatic disease defined as one of the following criteria: 1) One to four bone lesions; 2) One to four lung and/ or hepatic lesions; 3) Distant metastasis limited to ipsilateral cervical lymph nodes; 4) Distant metastasis limited to contralateral axillary lymph nodes
Oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablation
Disqualifiers
HER2-positive breast cancer
Progressive disease during the last systemic treatment received for metastatic disease
Previous local therapy for distant metastasis
Current or previous history of severe diseases, such as clinically relevant heart failure, acute myocardium infarction in the last six months, chronic obstructive lung disease, HIV infection, chronic active hepatitis B or C infection, current serious uncontrolled infections or other severe diseases that may impact patients' expected survival)
Trial design
Treatments tested in this trial
- Radiotherapy
- Surgery
- Radiofrequency ablation
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov