Trial Title:
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
NCT ID:
NCT05534438
Condition:
Oligometastatic Breast Carcinoma
Breast Cancer
Metastatic Breast Cancer
Metastatic Breast Carcinoma
ER+ Breast Cancer
HER2+ Breast Cancer
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiotherapy
Description:
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)
Arm group label:
Participants with oligometastatic breast cancer
Other name:
SBRT
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Xu, MD, PhD
Phone:
646-888-6863
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Xu, MD, PhD
Phone:
646-888-6863
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Xu, MD, PhD
Phone:
646-888-6863
Facility:
Name:
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Xu, MD, PhD
Phone:
646-888-6863
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Xu, MD, PhD
Phone:
646-888-6863
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Xu, MD, PhD
Phone:
646-888-6863
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Xu, MD, PhD
Phone:
646-888-6863
Facility:
Name:
Lehigh Valley Health Network (Data Collection Only)
Address:
City:
Allentown
Zip:
18103
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alyson McIntosh, MD
Phone:
610-402-0700
Start date:
September 6, 2022
Completion date:
September 6, 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05534438
http://www.mskcc.org
