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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

RECRUITINGPhase 2Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 2
SponsorMemorial Sloan Kettering Cancer Center
Started2022-09-06
Est. completion2026-09-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites

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

Age: 18 Years+Healthy volunteers 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.

Conditions7

Breast CancerCancerER+ Breast CancerHER2 + Breast CancerMetastatic Breast CancerMetastatic Breast CarcinomaOligometastatic Breast Carcinoma

Locations8 sites

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 10065
Amy Xu, MD, PhD646-888-6863
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Amy Xu, MD, PhD646-888-6863
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Amy Xu, MD, PhD646-888-6863
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Amy Xu, MD, PhD646-888-6863
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Amy Xu, MD, PhD646-888-6863

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