Single Fraction Stereotactic Body Radiation Therapy for Breast Cancer
This study is evaluating whether a new type of radiation treatment may help reduce the risk of breast cancer returning.
See full descriptionAbout the trial for Breast Cancer
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.
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.
Approximate Timelines
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.
Who is running the study
Principal InvestigatorPatient Q & A Section
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.