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New treatment option for Breast Cancer
Official title Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
ClinicalTrials.gov ID: NCT04698252
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency...
- Estrogen receptor-positive and/ or progesterone receptor-positive breast cancer
You likely can't join if
- 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...
- Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer
See the full eligibility 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...
- 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
- 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...
- Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.