Last updated 2 years ago
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
74 patients around the world
Available in Brazil
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.
Instituto do Cancer do Estado de São Paulo
1Research sites
74Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- Female sex≥ 18 years of ageHistologically 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 nodesOligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablationEstrogen receptor-positive and/ or progesterone receptor-positive breast cancerPartial response or stable disease after at least six months of systemic therapy for breast cancerEastern Cooperative Oncology Group (ECOG) performance status 0 or 1Measurable or non-measuble disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1Life expectancy of at least 12 weeksFor women in childbearing age, negative pregnancy test until 21 days before the date of study enrollment.Signed informed consent formDisposition and aptitude to fulfill the study protocol during the study duration
- HER2-positive breast cancerProgressive disease during the last systemic treatment received for metastatic diseasePrevious local therapy for distant metastasisCurrent 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)Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer
Sites
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
StudyLARA
SponsorInstituto do Cancer do Estado de São Paulo
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT04698252
