Metastases Directed Therapy for Oligometastatic Breast Cancer

NCT06144346 | Recruiting

• 1 other identifier: RO2309-308-080
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Metastatic Cancer; Metastatic Breast Cancer

Keywords

stereotactic radiation; oligometastatic breast cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival

  Time till disease progression

  from the time of randomization till disease progression or death up-to 120 months

• Overall Response rate

  rate of patients responding to therapy

  assessed using physical exam and PET CT after six months of systemic treatment

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

systemic and palliative treatment according to physician discretion

Other: Standard of Care

Metastases Directed Therapy

EXPERIMENTAL

SABR for all metastatic sites followed by systemic treatment for 6 months

Radiation: Stereotactic Ablative Radiation Therapy

Locoregional Treatment of the Primary

EXPERIMENTAL

patients who respond to MDT and ST will be randomized to undergo loco-regional treatment or not

Procedure: Locoregional treatment

Interventions

Stereotactic Ablative Radiation Therapy RADIATION

SABR to all metastatic lesions

Metastases Directed Therapy

Locoregional treatment PROCEDURE

mastectomy or BCS for the primary tumor

Locoregional Treatment of the Primary

Standard of Care OTHER

Systemic treatment and palliative treatment

Standard of Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Biological identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 to 70 years.
• Pathological evidence of breast cancer, any grade, any T stage.
• Radiological (at least) evidence of metastatic activity with maximum number of 5 extracranial lesions.
• Performance status ≤ 2
• No pre-existing conditions that may prohibit radiotherapy.

You may not qualify if:

• .Pregnant and lactating women.
• Prior radiotherapy to affected site(s) in less than a year.
• Active Connective tissue diseases (e.g Rheumatoid Arthritis).
• Progression to widespread metastatic disease
• Cases with brain metastasis

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Rimoun R Boutrus, M.D.

CONTACT

+201061056900; rimoun.boutrus@nci.cu.edu.eg

Joseph S Nayrouz, M.D.

CONTACT

+201272148324; j_nayrouz@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 22, 2023
• Study Start: September 20, 2023
• Primary Completion: August 19, 2025
• Study Completion (Estimated): September 20, 2028
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

EG (1)