Metastases Directed Therapy for Oligometastatic Breast Cancer

NCT06144346 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-22

No results posted yet for this study

Summary

This is a phase III randomized study evaluating the benefit from adding metastases directed therapy and locoregional treatment of the primary in breast cancer patients diagnosed with de novo oligometastatic disease patients will be randomized to receive the standard of care (SOC) treatment vs. systemic treatment + Stereotactic Ablative Radiation Therapy. Responders will be randomized to either undergo loco-regional management of the primary tumor or not

Conditions

Interventions

RADIATION

Stereotactic Ablative Radiation Therapy

SABR to all metastatic lesions

PROCEDURE

Locoregional treatment

mastectomy or BCS for the primary tumor

OTHER

Standard of Care

Systemic treatment and palliative treatment

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-08-19
Completion
2028-09-20

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144346 on ClinicalTrials.gov