Stereotactic Body Radiotherapy/SBRT for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Baptist Alliance - McI, Miami, FL
Breast Cancer+7 More
Stereotactic Body Radiotherapy/SBRT - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a type of radiation therapy may help slow the progression of cancer.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Metastatic Breast Cancer
  • Metastatic Non-Small Cell Lung Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Stereotactic Body Radiotherapy/SBRT will improve 1 primary outcome and 1 secondary outcome in patients with Breast Cancer. Measurement will happen over the course of Up to 2 years.

Up to 2 years
Overall Survival
Progression Free Survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Standare of Care
Stereotactic Body Radiotherapy (SBRT) + Standard of Care

This trial requires 142 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stereotactic Body Radiotherapy/SBRT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Stereotactic Body Radiotherapy (SBRT) + Standard of CarePatients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.
Standare of Care
Drug
Patients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Baptist Alliance - McI - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Breast Cancer or one of the other 7 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Metastatic disease detected on imaging and histologically confirmed
Triple negative breast cancer (TNBC) (ER <1%, PR <1%, her-2-neu 0-1+ by IHC or FISH-negative or as determined by MD discretion)
ER+ breast cancer receiving chemotherapy regardless of HER2 status
Non-small cell lung cancer (NSCLC) without known targetable molecular alterations in EGFR, ALK, or ROS1
NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history of disease progression on first-line tyrosine kinase inhibitor Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic imaging)
Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5 or fewer discrete disease sites that are technically amendable to SBRT (with the exception that if the primary disease is not amendable to SBRT it is allowed to be treated with conventionally fractionated or hypfractionated radiotherapy).
Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment
Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment
If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
For de novo stage IV patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy. If the primary tumor or other locoregional disease has not been definitively treated and is not amendable to SBRT, it must be treated with conventionally fractionated or hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10. If the clinical scenario deem that other forms of local therapy may be more suitable for the primary and locoregional disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes breast cancer?

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The breast is surrounded by adipocytes and it is possible that the secretion by these cells, both in vitro and in vivo, could cause insulin resistance inducing the onset of insulin-like growth-factor 1 expression, thus the upregulation of growth and survival factors. On the other hand, there is growing evidence that the up-regulation of growth factors in the tumor could be involved as a new mechanism of drug resistance, that lead to the failure of therapy, or a mechanism for metastasis at the primary tumor site.

Unverified Answer

What are the signs of breast cancer?

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There are few signs or symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the early stages of the disease. Most signs and symptoms of breast cancer are caused by other medical conditions. However, there are a few non-specific signs and symptoms that are commonly associated with breast cancer. These include: a lump or a lump on the breast, swollen lymph nodes, and nipple discharge. Diagnosing breast cancer can be difficult considering the heterogeneity of the presentation of this disease. A complete medical history, an assessment of symptoms, and breast exams are recommended for diagnosing early stage breast cancer, especially lumpectomy.

Unverified Answer

Can breast cancer be cured?

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Recent findings show that after 5 years of follow-up, a significant fraction of the patients (17.1%) had died of breast cancer (95% confidence interval (CI), 10.8-25.8: P=0.027). Five-year survival estimates ranged from 72.3% to 94.2%, with a median survival time of 71.5 months. The five-year cause-specific survival rate was 89.7% (95% CI, 81.1-97.3). There was a significant time-dependent increase in survival rates that was not statistically significant in univariated analyses (P=0.

Unverified Answer

What is breast cancer?

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Breast cancer is a common cancer that affects people of all ages in all parts of the world. It is also the most devastating form of cancer due to its high fatality rate. Many people do not become aware of breast cancer risks until it does occur. As the global incidence of breast cancers is rising, so does its potential of metastasis and fatality rates.

Unverified Answer

What are common treatments for breast cancer?

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Most common cancers and treatments included surgery, chemotherapy, hormonal treatments, radiation, and targeted therapies. However, some cancers and treatments required multidrug therapies. There is a significant lack of knowledge regarding treatment for many sub-groups such as older and those who have diabetes.

Unverified Answer

How many people get breast cancer a year in the United States?

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The American Cancer Society estimates that more than two million women in the United States will be diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the years ahead.

Unverified Answer

Does stereotactic body radiotherapy/sbrt improve quality of life for those with breast cancer?

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The improvement in quality of life seen from SBRT was independent of baseline scores (suggesting that it was not simply a case of regression toward the mean and not any specific effect on QOL). The SBRT treatment in our study was not found to increase QOL.

Unverified Answer

What is stereotactic body radiotherapy/sbrt?

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Stereotactic body radiotherapy is a therapeutic option in the treatment of advanced breast cancer, which is associated with high tumor control and a reduction (by 30%) in axillary nodal disease. The potential advantages of the SBRT are the minimal invasiveness, the very rapid reduction of pain when compared to that seen with traditional radical mastectomy with axillary dissection, and a preservation of most of the axillary lymph nodes.

Unverified Answer

Who should consider clinical trials for breast cancer?

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Breast cancer patients who wish to participate in a new clinical trial should consider the factors and goals listed in the article. Those who wish to participate in a clinical trial should consider clinical trial participation as a potential tool for improving overall breast cancer survival.

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What is the survival rate for breast cancer?

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There is no consistent agreement in the literature about what the prognosis is after treatment for breast cancer. We demonstrate that the prognosis is dependent on factors like stage of the disease, the presence and extent of metastatic disease, and the age of the patient. Furthermore, we find that after a median interval of 11 years, the survival rate seems to be around 92.6% when adjusted for age and stage of the disease.

Unverified Answer

What does stereotactic body radiotherapy/sbrt usually treat?

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I would argue that stereotactic body radiotherapy is not frequently used to target the primary masses of breast cancer because of a number of challenges associated with achieving a thorough and precise target. Even when the primary breast cancer is not the only location, I frequently use this technique for treating additional peripheral masses of breast cancer. These distant metastases may include bone alone or bone with visceral disease elsewhere in the chest wall. The goal here is to apply this technology to treat these extra tumors so that patients who were previously ineligible to have surgery can now proceed to have surgical resection of these extra tumors.

Unverified Answer

What is the average age someone gets breast cancer?

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The mean age is 51.1 for breast cancers diagnosed in women over 50. It is 49 for diagnosed in women under 50. The number of women diagnosed with breast cancer increases from 47 million in 1995 to 65 million in 2012; the percentage of women diagnosed with breast cancer has not changed much. There are around 250,000 new cases of breast cancer diagnosed each year and about 10,000 women die from breast cancer.\n

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