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NCT05534438 | RECRUITING | Oligometastatic Breast Carcinoma

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

Memorial Sloan Kettering Cancer Center

Brief Summary:

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.

Condition or disease

Oligometastatic Breast Carcinoma

Breast Cancer

Metastatic Breast Cancer

Metastatic Breast Carcinoma

ER+ Breast Cancer

HER2+ Breast Cancer

Intervention/treatment

Stereotactic body radiotherapy

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Actual Study Start Date : 2022-09-06
Estimated Primary Completion Date : 2026-09-06
Estimated Study Completion Date : 2026-09-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age 18 or older
  • * Willing and able to provide informed consent
  • * Metastatic breast cancer, biopsy proven
  • * ER+/HER2-, defined as \>5% ER+ staining
  • * HER2+ (regardless of ER status), including HER2-low and high expressors
  • * History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)
  • * Isolated site of disease progression on FDG PET scan
  • * Consented to 12-245
  • * ECOG performance status 0-1
Exclusion Criteria
  • * Pregnancy
  • * Serious medical comorbidity precluding radiation, including connective tissue disorders
  • * Intracranial disease (including previous intracranial involvement)
  • * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

Location Details

NCT05534438

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 10065

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

NOT YET RECRUITING

United States, Pennsylvania

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, United States, 18103