Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy, Surgery, Radiofrequency ablation.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized Trial
Overview
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.
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. 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.
Interventions
- Radiation Radiotherapy
Radiation therapy for oligometastatic sites - Procedure Surgery
Surgery for oligometastatic sites - Other Radiofrequency ablation
Radiofrequency ablation for oligometastatic sites
Primary outcome measures
- 2-year progression-free survival (PFS) [Time frame: from baseline up to 2 years]
Secondary outcome measures (6)
- Overall-survival (OS) [Time frame: from baseline up to 10 years]
- Local therapy complication rate [Time frame: from baseline up to 10 years]
- 1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) [Time frame: from baseline up to 1 year]
- 2. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23) [Time frame: from baseline up to 1 year]
- Chemotherapy-free survival [Time frame: from baseline up to 10 years]
- Subgroup analysis - PFS according to type of metastatic disease (de novo versus recurrent) and metastatic sites [Time frame: from baseline up to 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- ICESP — São Paulo
Identifiers
NCT: NCT04698252 · 1752/20