RECRUITING

A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

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Conditions

Oligometastatic Breast CarcinomaBreast CancerMetastatic Breast CancerMetastatic Breast CarcinomaER+ Breast CancerHER2+ Breast Canceroligometastatic breast cancerStereotactic Body Radiation Therapy22-259Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.

Official Title

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Quick Facts

Study Start:2022-09-06
Study Completion:2025-09-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05534438

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * Willing and able to provide informed consent
  3. * Metastatic breast cancer, biopsy proven
  4. * ER+/HER2-, defined as \>5% ER+ staining
  5. * HER2+ (regardless of ER status), including HER2-low and high expressors
  6. * History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)
  7. * Isolated site of disease progression on FDG PET scan
  8. * Consented to 12-245
  9. * ECOG performance status 0-1
  1. * Pregnancy
  2. * Serious medical comorbidity precluding radiation, including connective tissue disorders
  3. * Intracranial disease (including previous intracranial involvement)
  4. * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.

Contacts and Locations

Study Contact

Amy Xu, MD, PhD
CONTACT
646-888-6863
xua@mskcc.org
Atif Khan, MD
CONTACT
848-225-6334
khana7@mskcc.org

Principal Investigator

Amy Xu, MD, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 10065
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 18103
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Amy Xu, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-06
Study Completion Date2025-09-06

Study Record Updates

Study Start Date2022-09-06
Study Completion Date2025-09-06

Terms related to this study

Keywords Provided by Researchers

  • oligometastatic breast cancer
  • breast cancer
  • ER+ Breast Cancer
  • HER2+ Breast Cancer
  • Metastatic Breast Cancer
  • Stereotactic Body Radiation Therapy
  • 22-259
  • Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

  • Oligometastatic Breast Carcinoma
  • Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic Breast Carcinoma
  • ER+ Breast Cancer
  • HER2+ Breast Cancer