Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstituto do Cancer do Estado de São Paulo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Radiotherapy
RadiationRadiation therapy for oligometastatic sites
Surgery
Procedure/SurgerySurgery for oligometastatic sites
Radiofrequency ablation
Other interventionRadiofrequency ablation for oligometastatic sites
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Systemic therapyNo intervention 0 interventions
Group B: Local therapy + systemic therapyExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
2-year progression-free survival (PFS)
PFS will be defined as the time from randomization until the date of progression or death. 2-year PFS rate will represent the probability of a patient being free of progression after 2 years of randomization and will be estimated using the Kaplan-Meier method.
Time frame
from baseline up to 2 yearsSecondary outcomes
1
Overall-survival (OS)
OS will be calculated from the date of randomization until the date of death from any cause.
Time frame
from baseline up to 10 years2
Local therapy complication rate
Local therapy complications will be registered, including the occurrence of bleeding, local infections, pneumothorax, or other events attributed to local therapy by the medical team. Acute complications will be considered as those occurring until one month after procedure, while late complication will be those occurring later than one month.
Time frame
from baseline up to 10 years3
1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
The EORTC QLQ-C30 provide points for questions related to global health status, functional scales, and symptom scales, providing scores ranging from 0-100. Higher scores represent higher health status, higher functioning, and higher symptom burden.
Time frame
from baseline up to 1 year4
2. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
EORTC-QLQ-BR23 is composed of questions related to functional scales and symptom scales specific for breast cancer, providing scores ranging from 0-100. Higher scores for functional scales represent better functioning, while higher scores for symptom scales represent higher levels of symptoms.
Time frame
from baseline up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov