Status:
RECRUITING
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 imp...
Detailed Description
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. Patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04698252
Start Date
April 1 2021
End Date
April 1 2031
Last Update
August 8 2022
Active Locations (1)
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1
ICESP
São Paulo, São Paulo, Brazil, 01246-000