Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

NCT ID: NCT04698252

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2031-04-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Systemic therapy

Patients will receive standard of care with systemic therapy alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

Radiation therapy for oligometastatic sites

Surgery

Intervention Type: PROCEDURE

Surgery for oligometastatic sites

Radiofrequency ablation

Intervention Type: OTHER

Radiofrequency ablation for oligometastatic sites

Interventions

Radiotherapy

Radiation therapy for oligometastatic sites

Intervention Type: RADIATION

Surgery

Surgery for oligometastatic sites

Intervention Type: PROCEDURE

Radiofrequency ablation

Radiofrequency ablation for oligometastatic sites

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renata C. Bonadio, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de São Paulo

Locations

ICESP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Renata C. Bonadio, MD

Role: CONTACT

rrccbonadio@gmail.com

+5511989554040

Facility Contacts

Renata Bonadio, MD

Role: primary

rrccbonadio@gmail.com

+551138932000

Other Identifiers

1752/20

Identifier Type: -

Identifier Source: org_study_id