Actively Recruiting
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2022-08-08
74
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- 18 years of age or older
- Histologically confirmed invasive breast cancer with oligometastatic disease defined as one to four bone lesions, one to four lung and/or liver lesions, or distant metastasis limited to ipsilateral cervical or contralateral axillary lymph nodes
- Oligometastatic sites suitable for local therapy 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable or non-measurable disease by RECIST 1.1 criteria
- Life expectancy of at least 12 weeks
- Negative pregnancy test for women of childbearing potential within 21 days before enrollment
- Signed informed consent
- Ability and willingness to follow study protocol during the study period
You will not qualify if you...
- HER2-positive breast cancer
- Progressive disease during the last systemic treatment for metastatic disease
- Previous local therapy for distant metastasis
- History of severe diseases such as significant heart failure, recent acute myocardial infarction (within 6 months), chronic obstructive lung disease, HIV infection, chronic active hepatitis B or C, serious uncontrolled infections, or other severe illnesses impacting expected survival
- History of other invasive cancers within the last 5 years, except non-melanoma skin cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
ICESP
São Paulo, São Paulo, Brazil, 01246-000
Actively Recruiting
Research Team
R
Renata C. Bonadio, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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