CLINICAL TRIAL

Single Fraction Stereotactic Body Radiation Therapy for Breast Cancer

Recruiting · 18+ · All Sexes · Birmingham, AL

This study is evaluating whether a new type of radiation treatment may help reduce the risk of breast cancer returning.

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About the trial for Breast Cancer

Eligible Conditions
Breast Cancer · Breast Neoplasms

Treatment Groups

This trial involves 2 different treatments. Single Fraction Stereotactic Body Radiation Therapy is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Single Fraction Stereotactic Body Radiation Therapy
RADIATION
Experimental Group 2
5 Fraction Stereotactic Body Radiation Therapy
RADIATION

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient must be clinically node negative by physical examination show original
Pathologically confirmed invasive mammary carcinoma, including invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast show original
Age>50.
Zubrod performance status is 0-2. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 0-2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 0-2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Single Fraction Stereotactic Body Radiation Therapy will improve 2 primary outcomes and 2 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 0-2 years.

Toxicity levels of 5 fraction SBRT for partial breast irradiation assessed by CTCAE v4.0
0-2 YEARS
To determine the safety of five fraction SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.
Toxicity levels of single fraction SBRT for partial breast irradiation assessed by CTCAE v4.0
0-2 YEARS
To determine the safety of single fraction SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.
Cosmetic outcome post-SBRT
0-2 YEARS
To determine patient and nurse assessed cosmetic outcome at 1, 6, 12, 18, 24, and 36 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT.
Toxicity of breast SBRT using CTCAE v4.0
0-2 YEARS
To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy.

Who is running the study

Principal Investigator
D. H. B.
Drexell Hunter Boggs, Radiation Oncologist
University of Alabama at Birmingham

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 are the signs of breast cancer?

There are a number of specific signs people should look for and note when they go for a medical examination: breast lumps and nipple discharge are fairly reliable signs of breast cancer, whereas unexplained persistent swelling, pain, a lump or a hard mass is not.

Anonymous Patient Answer

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

Approximately 190,000 women develop breast cancer each year in the United States. The average age at diagnosis for breast cancer is 62.2 years and the disease tends to occur in older women. However, there is evidence that increased use of screening mammography has led to an earlier and earlier detection of breast cancer among younger women. On average, women live approximately 2 years longer after diagnosis, presumably due to aggressive treatment, so that approximately 21% of women will live at least five years after a diagnosis of breast cancer.

Anonymous Patient Answer

Can breast cancer be cured?

Despite advances in treatment and increased awareness of breast cancer, breast cancer continues to be an important health issue in the UK in terms of deaths and disability, and its cure remains elusive.

Anonymous Patient Answer

What causes breast cancer?

Breast cancer is a genetically complex disorder; in the overwhelming majority of cases, breast cancer arises as a result of mutations in one or more of the genes encoding proteins that function in the formation of the ER and PR pathways of estrogen and progesterone signaling. A subset of individuals with BRCA1/2 mutations are at elevated risk for breast cancer and may benefit from additional preventive measures for breast cancer, including mastectomy and prophylactic chemotherapy.

Anonymous Patient Answer

What is breast cancer?

Breast cancer is a deadly disease that can form in the breast tissues. The tumor and the tumor cells that form it can invade other tissues, spread to other organs, and form metastases, which are the cells that grow and spread outside the original site in the body. To find whether the tumor cell will spread to other organs and form metastases, it is imperative to obtain histological and physical characteristics of the primary tumor. The clinical manifestations of breast cancer depend on the type of tumor and how far the tumor has spread. The two main types of breast cancer are ductal carcinoma in situ and invasive ductal carcinoma. Signs of breast cancer are redness, lumpiness, or a change in the shape of the nipple.

Anonymous Patient Answer

What are common treatments for breast cancer?

While some treatments, like surgery, are the most commonly used treatments for breast cancer, many others are commonly used. These include chemotherapy, radiotherapy, targeted therapies, and traditional therapies. All of these treatments appear to be safe and effective. Breast cancers that persist or disseminate into the chest or regional lymph nodes are more likely to be treated with surgery, radiotherapy, or chemotherapy.\n

Anonymous Patient Answer

Does single fraction stereotactic body radiation therapy improve quality of life for those with breast cancer?

Single fraction stereotactic radiation is safe and can improve Quality of Life in selected patients and may be a viable therapy approach for those in the early stages of their cancer as well as those with larger volumes of locally recurrent disease.

Anonymous Patient Answer

What are the common side effects of single fraction stereotactic body radiation therapy?

The toxicity grade was ≥ 3 in 15% of all patients. The most commonly documented side effects were: fever, nausea, muscle pains, headache, fatigue, and insomnia. Fatigue and insomnia were the sole toxicities present at the second week after SBRT that resulted in dose reduction or treatment interruption. The majority of the reported severe toxicities were local reactions, such as dermatitis and swelling. There were no treatment-related severe pneumonitis or lymphedema.

Anonymous Patient Answer

What is the primary cause of breast cancer?

When considering the primary cause of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), it is important to understand that the disease has been found to be both intrinsic and extrinsic to the breasts. The extrinsic causes of breast cancer include lifestyle, diet and exposure to environmental factors (such as asbestos and chemicals). These external factors can alter the cells of the breasts and initiate tumours in this organ.\n\n- Breast reconstruction: Breast prostheses are surgically implanted after mastectomy; some patients have previously had breast augmentation surgery. Implants are also used: for cosmetic reasons and breast reconstruction.

Anonymous Patient Answer

What are the chances of developing breast cancer?

Breast cancer in BRCA1/2 mutation carriers is more frequent and more advanced, but has the same prognosis, treatment response and disease-free and overall survival compared to BRCA2 carriers. Results from a recent clinical trial highlights the relevance of knowing the BRCA1/2 carrier status of a family that developed breast cancer.

Anonymous Patient Answer

What is the survival rate for breast cancer?

The overall survival and disease-free survival rates of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) (when diagnosed with a node-positive cancer) were excellent--close to 95% for a median of 20 years. However, there was less good survival when cancer was diagnosed on the axilla (chest wall). The survival rates were even better for breast cancer in younger women with very early stages of the disease, such as stage one and stages 2A and 2B.

Anonymous Patient Answer

Is single fraction stereotactic body radiation therapy safe for people?

At our institution, SBRT was well tolerated but was not feasible in all patients. The most common failures were due to poor tumor response, poor target placement, or both. SBRT appears to have a role in select situations, especially in settings in which it can be delivered quickly in a highly accurate manner.

Anonymous Patient Answer
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