Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

NCT04698252 | Recruiting Phase 2

• 1 other identifier: 1752/20
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Oligometastasis; Hormone Receptor Positive; Surgery; Radiotherapy; Radiofrequency ablation

Outcome Measures

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.

  from baseline up to 2 years

Secondary Outcomes (6)

• Overall-survival (OS)

  from baseline up to 10 years

• Local therapy complication rate

  from baseline up to 10 years

• 1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)

  from baseline up to 1 year

• 2. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)

  from baseline up to 1 year

• Chemotherapy-free survival

  from baseline up to 10 years

Study Arms (2)

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.

Radiation: Radiotherapy; Procedure: Surgery; Other: Radiofrequency ablation

Interventions

Radiotherapy RADIATION

Radiation therapy for oligometastatic sites

Local therapy + systemic therapy

Surgery PROCEDURE

Surgery for oligometastatic sites

Local therapy + systemic therapy

Radiofrequency ablation OTHER

Radiofrequency ablation for oligometastatic sites

Local therapy + systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

ICESP

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy; Surgical Procedures, Operative; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiofrequency Therapy; Ablation Techniques

Study Officials

• Renata C. Bonadio, MD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renata C. Bonadio, MD

CONTACT

+5511989554040; rrccbonadio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 6, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2024
• Study Completion (Estimated): April 1, 2031
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

BR (1)