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Local Therapy for ER/PR-positive Oligometastatic Breast Cancer (LARA)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Radiotherapy
Surgery
Radiofrequency ablation
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Oligometastasis, Hormone Receptor Positive, Surgery, Radiotherapy, Radiofrequency ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • ICESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Systemic therapy

Local therapy + systemic therapy

Arm Description

Patients will receive standard of care with systemic therapy alone.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall-survival (OS)
OS will be calculated from the date of randomization until the date of death from any cause.
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.
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.
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.
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.
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

Full Information

First Posted
December 4, 2020
Last Updated
August 5, 2022
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04698252
Brief Title
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer
Acronym
LARA
Official Title
Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Oligometastasis, Hormone Receptor Positive, Surgery, Radiotherapy, Radiofrequency ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systemic therapy
Arm Type
No Intervention
Arm Description
Patients will receive standard of care with systemic therapy alone.
Arm Title
Local therapy + systemic therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiation therapy for oligometastatic sites
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery for oligometastatic sites
Intervention Type
Other
Intervention Name(s)
Radiofrequency ablation
Intervention Description
Radiofrequency ablation for oligometastatic sites
Primary Outcome Measure Information:
Title
2-year progression-free survival (PFS)
Description
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 years
Secondary Outcome Measure Information:
Title
Overall-survival (OS)
Description
OS will be calculated from the date of randomization until the date of death from any cause.
Time Frame
from baseline up to 10 years
Title
Local therapy complication rate
Description
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 years
Title
1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
Description
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 year
Title
2. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
Description
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 year
Title
Chemotherapy-free survival
Description
Chemotherapy-free survival will be calculated from the date of randomization until the first date of application of a new chemotherapy line.
Time Frame
from baseline up to 10 years
Title
Subgroup analysis - PFS according to type of metastatic disease (de novo versus recurrent) and metastatic sites
Description
PFS will be calculated for subgroups, according to type of metastatic disease (de novo versus recurrent) and sites of oligometastasis
Time Frame
from baseline up to 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renata C. Bonadio, MD
Phone
+5511989554040
Email
rrccbonadio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata C. Bonadio, MD
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICESP
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Bonadio, MD
Phone
+551138932000
Email
rrccbonadio@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

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