Recruiting
Phase 2

Radiation Therapy with Drug Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05534438

Conditions

Oligometastatic Breast Carcinoma

Breast Cancer

Metastatic Breast Cancer

Metastatic Breast Carcinoma

ER+ Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic body radiotherapy

Study Details

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.

Conditions

Oligometastatic Breast Carcinoma

Breast Cancer

Metastatic Breast Cancer

Metastatic Breast Carcinoma

ER+ Breast Cancer

Study ID

NCT05534438

Start date

Sep 6, 2022

Status verified date

Jul, 2026

Completion date

Sep 6, 2026

Anticipated

Primary completion date

Sep 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Stereotactic body radiotherapy

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

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

Central Contacts and Locations

Central contacts

Amy Xu, MD, PhD

646-888-6863xua@mskcc.org

Atif Khan, MD

848-225-6334khana7@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 10065

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Amy Xu, MD, PhD

646-888-6863

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-10.