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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05534438
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic body radiotherapy — RADIATION
    SBRT will be initiated as soon as possible, at not beyond 8 weeks of baseline measurements. Recommended dosing is per department standards for oligometastatic disease (ie, 10 Gy x 3 or 7-8 Gy x 5 fractions daily, excluding weekends and departmental holidays)

Study Details

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.

Key Dates

Start date
Sep 6, 2022
Status verified
Apr 2026
Primary completion
Sep 6, 2026
Completion
Sep 6, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with oligometastatic breast cancer
    Participants with oligometastatic breast cancer with isolated progression after sustained (\>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.

Primary Outcome Measure

Progression free survival [ Time Frame: 3 months from start of SBRT delivery ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey10065
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Amy Xu, MD, PhD
646-888-6863
Lehigh Valley Health Network (Data Collection Only)AllentownPennsylvania18103
Alyson McIntosh, MD
610-402-0700

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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