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.
Patients with estrogen receptor/ progesterone receptor-positive oligometastatic breast cancer with disease controlled after at least six months of systemic therapy will be enrolled in the study. Patients will be randomized to receive local therapy for oligometastatic sites in addition to systemic therapy or systemic therapy alone. Local therapy strategies will include surgery, radiotherapy, and radiofrequency ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Radiation therapy for oligometastatic sites
Surgery for oligometastatic sites
Radiofrequency ablation for oligometastatic sites
ICESP
São Paulo, São Paulo, Brazil
RECRUITING2-year progression-free survival (PFS)
PFS will be defined as the time from randomization until the date of progression or death. 2-year PFS rate will represent the probability of a patient being free of progression after 2 years of randomization and will be estimated using the Kaplan-Meier method.
Time frame: from baseline up to 2 years
Overall-survival (OS)
OS will be calculated from the date of randomization until the date of death from any cause.
Time frame: from baseline up to 10 years
Local therapy complication rate
Local therapy complications will be registered, including the occurrence of bleeding, local infections, pneumothorax, or other events attributed to local therapy by the medical team. Acute complications will be considered as those occurring until one month after procedure, while late complication will be those occurring later than one month.
Time frame: from baseline up to 10 years
1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
The EORTC QLQ-C30 provide points for questions related to global health status, functional scales, and symptom scales, providing scores ranging from 0-100. Higher scores represent higher health status, higher functioning, and higher symptom burden.
Time frame: from baseline up to 1 year
2. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
EORTC-QLQ-BR23 is composed of questions related to functional scales and symptom scales specific for breast cancer, providing scores ranging from 0-100. Higher scores for functional scales represent better functioning, while higher scores for symptom scales represent higher levels of symptoms.
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Time frame: from baseline up to 1 year
Chemotherapy-free survival
Chemotherapy-free survival will be calculated from the date of randomization until the first date of application of a new chemotherapy line.
Time frame: from baseline up to 10 years
Subgroup analysis - PFS according to type of metastatic disease (de novo versus recurrent) and metastatic sites
PFS will be calculated for subgroups, according to type of metastatic disease (de novo versus recurrent) and sites of oligometastasis
Time frame: from baseline up to 10 years