Breast CancerPhase 2LARANCT04698252
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
A Phase 2 study testing Radiotherapy, Surgery and Radiofrequency ablation in people with Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy, Surgery and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2021to 1 Apr 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
ICESP
São Paulo, São Paulo, 01246-000
Renata Bonadio, MD, +551138932000, rrccbonadio@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy, Surgery, Radiofrequency ablation
- Keywords
- Oligometastasis, Hormone Receptor Positive, Surgery, Radiotherapy, Radiofrequency ablation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiation therapy for oligometastatic sites
SurgeryProcedure or surgery
Surgery for oligometastatic sites
Radiofrequency ablationOther
Radiofrequency ablation for oligometastatic sites
| Study group | Role | What they receive |
|---|---|---|
| Systemic therapy | No intervention | Patients will receive standard of care with systemic therapy alone. |
| Local therapy + systemic therapy | Experimental | 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. Receives: Radiation: Radiotherapy; Procedure: Surgery; Other: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline up to 2 years
Secondary outcomes (6)
Overall-survival (OS)
OS will be calculated from the date of randomization until the date of death from any cause.
Measured: from baseline up to 10 years
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.
Measured: from baseline up to 10 years
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.
Measured: from baseline up to 1 year
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.
Measured: from baseline up to 1 year
Chemotherapy-free survival
Chemotherapy-free survival will be calculated from the date of randomization until the first date of application of a new chemotherapy line.
Measured: from baseline up to 10 years
Subgroup analysis - PFS according to type of metastatic disease (de novo versus recurrent) and metastatic sites
PFS will be calculated for subgroups, according to type of metastatic disease (de novo versus recurrent) and sites of oligometastasis
Measured: from baseline up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renata C. Bonadio, MD, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698252
- Sponsor's protocol ID
- 1752/20
- Acronym
- LARA
- Status last verified
- Aug 2022
- First submitted
- 4 Dec 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized Trial
- ClinicalTrials.gov ID
- NCT04698252
- Acronym / sponsor ID
- LARA / 1752/20
- Conditions
- Breast Cancer
- Keywords
- Oligometastasis, Hormone Receptor Positive, Surgery, Radiotherapy, Radiofrequency ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic therapy | No intervention | –Patients will receive standard of care with systemic therapy alone. |
| Local therapy + systemic therapy | Experimental | Radiation: Radiotherapy, Procedure: Surgery, Other: Radiofrequency ablationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiation therapy for oligometastatic sites | Radiation | Local therapy + systemic therapy |
| SurgerySurgery for oligometastatic sites | Procedure or surgery | Local therapy + systemic therapy |
| Radiofrequency ablationRadiofrequency ablation for oligometastatic sites | Other | Local therapy + systemic therapy |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renata C. Bonadio, MD principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Surgery and Radiofrequency ablation in people with Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renata C. Bonadio, MD (+5511989554040, rrccbonadio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (PFS) (time frame: from baseline up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.