- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698252
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer (LARA)
August 5, 2022 updated by: Instituto do Cancer do Estado de São Paulo
Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
74
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Renata C. Bonadio, MD
- Phone Number: +5511989554040
- Email: rrccbonadio@gmail.com
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01246-000
- Recruiting
- ICESP
-
Contact:
- Renata Bonadio, MD
- Phone Number: +551138932000
- Email: rrccbonadio@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Systemic therapy
Patients will receive standard of care with systemic therapy alone.
|
|
Experimental: Local therapy + systemic therapy
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.
|
Radiation therapy for oligometastatic sites
Surgery for oligometastatic sites
Radiofrequency ablation for oligometastatic sites
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-year progression-free survival (PFS)
Time Frame: from baseline up to 2 years
|
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.
|
from baseline up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall-survival (OS)
Time Frame: from baseline up to 10 years
|
OS will be calculated from the date of randomization until the date of death from any cause.
|
from baseline up to 10 years
|
Local therapy complication rate
Time Frame: from baseline up to 10 years
|
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.
|
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
|
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.
|
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
|
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.
|
from baseline up to 1 year
|
Chemotherapy-free survival
Time Frame: from baseline up to 10 years
|
Chemotherapy-free survival will be calculated from the date of randomization until the first date of application of a new chemotherapy line.
|
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
|
PFS will be calculated for subgroups, according to type of metastatic disease (de novo versus recurrent) and sites of oligometastasis
|
from baseline up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Renata C. Bonadio, MD, Instituto do Cancer do Estado de Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
April 1, 2024
Study Completion (Anticipated)
April 1, 2031
Study Registration Dates
First Submitted
December 4, 2020
First Submitted That Met QC Criteria
January 5, 2021
First Posted (Actual)
January 6, 2021
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 5, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1752/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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