Clinical trial · Interventional
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized Trial
NCT04698252CI-TRIAL-00060159LARArecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation | Other | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Systemic therapy
- description
- Patients will receive standard of care with systemic therapy alone.
- type
- EXPERIMENTAL
- label
- Local therapy + systemic therapy
- description
- In addition to systemic therapy, patients will receive local therapy for all oligometastatic sites. Options of local therapy will be radiotherapy, radiofrequency ablation, and/ or surgery.
- interventionNames
- Radiation: Radiotherapy
- Procedure: Surgery
- Other: Radiofrequency ablation
Primary outcomes (1)
- measure
- 2-year progression-free survival (PFS)
- timeFrame
- from baseline up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.