Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
Recruiting · NCT04698252 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto do Cancer do Estado de São Paulo
View the official record on ClinicalTrials.gov →Interventions studied
Radiofrequency ablationRadiotherapySurgery
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Estrogen receptor-positive and/ or progesterone receptor-positive breast cancer
- Partial response or stable disease after at least six months of systemic therapy for breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable or non-measuble disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Life expectancy of at least 12 weeks
- For women in childbearing age, negative pregnancy test until 21 days before the date of study enrollment.
- Signed informed consent form
- Disposition and aptitude to fulfill the study protocol during the study duration
Exclusion criteria
- 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)
- Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer
Where it is running
1 location listed.
- ICESP - São Paulo, São Paulo, Brazil