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

Primary Purpose

Oligometastatic Breast Carcinoma, Breast Cancer, Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic body radiotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligometastatic Breast Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
  • Lehigh Valley Health Network (Data Collection Only)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with oligometastatic breast cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression free survival
The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2022
Last Updated
July 3, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05534438
Brief 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
Official Title
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
September 6, 2025 (Anticipated)
Study Completion Date
September 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with oligometastatic breast cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiotherapy
Other Intervention Name(s)
SBRT
Intervention 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)
Primary Outcome Measure Information:
Title
Progression free survival
Description
The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.
Time Frame
3 months from start of SBRT delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Email
xua@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Atif Khan, MD
Phone
848-225-6334
Email
khana7@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Lehigh Valley Health Network (Data Collection Only)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyson McIntosh, MD
Phone
610-402-0700

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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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