Targeted Radiation + Drug Therapy for Breast Cancer

Recruiting at 8 trial locations

Overseen By Amy Xu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Connective tissue disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating breast cancer that has spread to a few specific areas. It combines targeted radiation therapy, known as Stereotactic Body Radiation Therapy (SBRT), with the patient's usual drug treatment. The goal is to determine if this combination can prevent the cancer from worsening or spreading further. Suitable candidates have breast cancer that has spread but have maintained a stable response to drug treatment for at least six months, with only one area showing signs of worsening. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants will stay on their usual drug therapy while receiving the targeted radiation treatment.

What prior data suggests that Stereotactic Body Radiation Therapy is safe for treating oligometastatic breast cancer?

Research shows that stereotactic body radiotherapy (SBRT) is a safe treatment for breast cancer that has spread to a few other areas. Studies have found that SBRT is non-invasive, meaning it doesn't involve surgery, and patients generally tolerate it well. One study found that SBRT effectively targets and treats the cancer site without causing major problems. Although some evidence remains limited, SBRT is already used for this type of cancer and can delay the need to change other cancer treatments by over a year. Overall, SBRT appears to be a safe option for many patients dealing with certain types of breast cancer spread. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for breast cancer?

Researchers are excited about using stereotactic body radiotherapy (SBRT) for breast cancer because it offers precision targeting of cancerous lesions. Unlike traditional radiation, which can affect a broader area and sometimes healthy tissue, SBRT focuses high-dose radiation directly on the tumor, minimizing damage to surrounding healthy cells. This precision is particularly beneficial for patients with oligometastatic breast cancer, where the cancer has spread to a limited number of sites. By integrating SBRT with ongoing systemic therapy, the treatment aims to effectively control isolated tumor progression while maintaining the overall regimen that the body is already responding to, potentially improving outcomes without significantly increasing side effects.

What evidence suggests that Stereotactic Body Radiation Therapy might be an effective treatment for oligometastatic breast cancer?

Research shows that stereotactic body radiotherapy (SBRT) can benefit patients with oligometastatic breast cancer, where the cancer has spread but not extensively. In this trial, participants with oligometastatic breast cancer will receive SBRT targeting the progressive lesion identified on imaging while continuing their current systemic therapy. Studies suggest that SBRT might extend survival for patients with this cancer type. One study found that SBRT delayed the need to change drug treatments, particularly for patients with estrogen receptor-positive breast cancer. Another study demonstrated that SBRT was effective for cancer that had spread to only a few areas. Overall, SBRT appears promising in slowing cancer growth and improving outcomes for patients with metastatic breast cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

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 metastatic breast cancer who've had a good response to drug therapy for at least 6 months. It's open to those with certain hormone receptor statuses, able to consent, and have only one site of disease progression visible on a scan. Pregnant individuals, those with previous radiation at the target site or brain involvement, and serious medical conditions that conflict with radiation are excluded.

Inclusion Criteria

My treatment for cancer has been working for at least 6 months without getting worse.

Consented to 12-245

My breast cancer has spread, confirmed by a biopsy.

Exclusion Criteria

I have a serious health condition that prevents me from receiving radiation therapy.

I've had radiation before where they now want to treat, and can't have more without risking harm.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive Stereotactic Body Radiation Therapy (SBRT) to a single metastatic site while maintaining their usual drug therapy

3 months

Follow-up

Participants are monitored for progression free survival and other outcomes after SBRT

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic body radiotherapy

Trial Overview The study tests adding Stereotactic Body Radiation Therapy (SBRT) targeting just one metastatic site alongside ongoing usual drug therapy in people with oligometastatic breast cancer. The goal is to see if this precise radiation can prevent the cancer from getting worse elsewhere.

How Is the Trial Designed?

Group I: Participants with oligometastatic breast cancer Experimental Treatment 1 Intervention

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.

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 ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

Stereotactic ablative body radiosurgery (SABR) and stereotactic body radiation therapy (SBRT) deliver high doses of radiation precisely to tumors, which may improve treatment outcomes compared to conventional low-dose radiation therapy (1.8-2Gy).

These advanced techniques not only enhance tumor ablation but also interact beneficially with biological and immunologic therapies, while incorporating methods to protect normal tissues, making them suitable for various types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). Folkert, MR., Timmerman, RD.[2022]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., et al.[2020]

Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative body radiotherapy (SABR) is a significant advancement in radiotherapy that has been shown to improve tumor control and overall survival in patients with lung tumors.

The review highlights the current evidence supporting the efficacy of SABR for both primary and secondary lung tumors, along with ongoing trials that may further validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. Goldsmith, C., Gaya, A.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329079/

Impact of stereotactic body radiation therapy on systemic ... Many studies of SBRT in patients with OMD highlighted that patient with BC had a potential for higher survival rate compared to other solid ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0936655524001092

Treatment Outcomes of Stereotactic Ablative Body ... This study reported SABR treatment outcomes for multisite OM and OP diseases originating from metastatic breast cancer.

3. ascopubs.org ascopubs.org/doi/10.1200/OA-25-00031

A Phase II Prospective Multicenter Trial This study suggests that SABR can help delay the need to change systemic therapy in patients with estrogen receptor–positive, human epidermal ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05377047

Stereotactic Ablative Radiotherapy for OligoMetastatic ... TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34624408/

Stereotactic body radiotherapy to treat breast cancer ... Stereotactic ablative radiotherapy (SABR) has been reported to be an effective treatment for oligometastatic disease from different primary cancer sites.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38575431/

Treatment Outcomes of Stereotactic Ablative Body ... This study confirmed that SABR was a safe, non-invasive treatment option for patients with extracranial OM and OP diseases originated from primary breast cancer ...

7. thebreastonline.com thebreastonline.com/article/S0960-9776(25)00563-6/fulltext

Impact of stereotactic body radiation therapy on systemic ... SBRT is widely used in oligometastatic breast cancer despite limited evidence. •. SBRT delayed systemic therapeutic line change by over 1 year in our cohort. •.