145 Participants Needed

SBRT + Standard of Care for Metastatic Breast Cancer

Recruiting at 17 trial locations
IZ
TJ
DY
WZ
AX
Overseen ByAmy Xu, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

Is SBRT combined with standard care safe for treating metastatic breast cancer?

Research shows that SBRT (Stereotactic Body Radiotherapy) is generally safe when combined with targeted therapy or immunotherapy for patients with metastatic cancer, although specific safety data for metastatic breast cancer is limited. Experts have developed guidelines to ensure safe use, focusing on managing risks and adjusting treatment as needed.12345

How is the SBRT + Standard of Care treatment different for metastatic breast cancer?

This treatment combines Stereotactic Body Radiotherapy (SBRT), a precise and high-dose radiation therapy, with standard systemic therapy to target both the primary tumor and its metastases. It is unique because it aims to improve survival by controlling cancer spread more effectively than standard treatment alone, especially in patients with a limited number of metastases.14678

What data supports the effectiveness of the treatment SBRT + Standard of Care for Metastatic Breast Cancer?

Research suggests that using Stereotactic Body Radiotherapy (SBRT) along with standard treatment can help control cancer spread and delay the need for further treatment in patients with a limited number of metastases (cancer spread to other parts of the body). This approach has shown promise in improving outcomes for patients with certain types of cancer, including breast cancer.14789

Who Is on the Research Team?

AX

Amy Xu, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain types of breast or non-small cell lung cancer that has spread (1-5 metastases). They should be able to undergo SBRT, have a performance status of 0-2, and not be pregnant. Excluded are those with serious health issues preventing radiotherapy, spinal cord compression signs, malignant effusions, another active cancer in the last year.

Inclusion Criteria

I am able to care for myself and perform daily activities.
I have two cancer lesions close together, treated as one.
I am a woman who cannot become pregnant or have tested negative for pregnancy.
See 14 more

Exclusion Criteria

Pregnant or lactating women
Joining this trial will not delay my current treatment plan.
You have other serious health problems that might make it unsafe for you to receive radiotherapy, as determined by your doctor.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Body Radiotherapy (SBRT) to all known metastases and continue standard of care therapy

Concurrent with SBRT

Follow-up

Participants are monitored for progression free survival and overall survival

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Stereotactic Body Radiotherapy/SBRT
  • Systemic Therapy/Standard of Care
Trial Overview The study tests if adding Stereotactic Body Radiotherapy (SBRT) to standard systemic therapy prolongs the time before worsening of metastatic breast or non-small cell lung cancer. It targets patients with limited sites of disease amenable to this precise radiation technique.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Body Radiotherapy (SBRT) + Standard of CareExperimental Treatment2 Interventions
Group II: Standare of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) for metastatic breast cancer showed high local control rates of 89% at 1 year and 86.6% at 2 years, indicating its effectiveness in managing metastatic lesions.
Patients with oligometastases had significantly better overall survival (83.5% at 1 year) and progression-free survival (66% at 1 year) compared to those with oligoprogression or local control of dominant tumor, suggesting that SBRT can delay the need for chemotherapy or hormonal therapy in these patients.
Outcomes of extra-cranial stereotactic body radiotherapy for metastatic breast cancer: Treatment indication matters.Tan, H., Cheung, P., Louie, AV., et al.[2021]
This multicenter randomized phase III trial aims to determine if combining Stereotactic Body Radiation Therapy (SBRT) with standard systemic treatment improves progression-free survival in patients with solid tumors and up to 3 bone-only metastases, with a total of 196 patients expected to be enrolled over 4 years.
The primary goal is to assess progression-free survival at 1 year, while secondary outcomes will evaluate local control, cancer-specific survival, quality of life, and pain management, highlighting the potential for SBRT to enhance patient outcomes by controlling bone metastases.
Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS).Thureau, S., Marchesi, V., Vieillard, MH., et al.[2021]
Stereotactic body radiotherapy (SBRT) is being increasingly considered for patients with oligometastatic breast cancer, which is defined as having 5 or fewer metastatic sites, as it may improve their prognosis through aggressive local treatment.
A survey of Canadian Medical Oncologists was conducted to understand their beliefs and opinions about the use of SBRT in this patient group, highlighting the need to identify the optimal scenarios for its implementation in clinical practice.
Attitudes and beliefs toward the use of stereotactic body radiotherapy in oligometastatic breast cancer: A commentary on a survey of Canadian Medical Oncologists.Donovan, E., Dhesy-Thind, S., Mukherjee, S., et al.[2020]

Citations

Outcomes of extra-cranial stereotactic body radiotherapy for metastatic breast cancer: Treatment indication matters. [2021]
Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). [2021]
Attitudes and beliefs toward the use of stereotactic body radiotherapy in oligometastatic breast cancer: A commentary on a survey of Canadian Medical Oncologists. [2020]
[Treatment of oligometastatic or oligoprogression cancer]. [2019]
Stereotactic body radiotherapy (SBRT) and concomitant systemic therapy in oligoprogressive breast cancer patients. [2022]
Stereotactic body radiation therapy: A promising chance for oligometastatic breast cancer. [2017]
Metastases-directed stereotactic body radiotherapy in combination with targeted therapy or immunotherapy: systematic review and consensus recommendations by the EORTC-ESTRO OligoCare consortium. [2023]
Multi-institutional phase I/II trial of stereotactic body radiation therapy for lung metastases. [2022]
Multi-institutional experience of stereotactic body radiotherapy for large (≥5 centimeters) non-small cell lung tumors. [2018]
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