Clinical trial NCT05534438: A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
Official title: Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Oligometastatic Breast Carcinoma
Breast Cancer
Metastatic Breast Cancer
Metastatic Breast Carcinoma
ER+ Breast Cancer
HER2+ Breast Cancer
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Progression free survival
timeFrame: 3 months from start of SBRT delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network (Data Collection Only)
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Amy Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: