Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

  • STATUS
    Recruiting
  • End date
    Aug 31, 2027
  • participants needed
    15
  • sponsor
    Stony Brook University
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Updated on 24 January 2021
See if I qualify
carcinoma
invasive breast cancer
invasive carcinoma

Summary

This is a prospective pilot study investigating the safety and efficacy of stereotactic body radiation therapy (SBRT) as a treatment for breast cancer in patients who do not get surgery. The study will accrue 15 patients who will be treated to a dose of 40 Gy over the course of 5 fractions in the Stony Brook University Hospital Department of Radiation Oncology. The subjects will then have a follow up time of 5 years.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Stereotactic Body Radiation Therapy (SBRT)
Clinical Study IdentifierNCT04532177
SponsorStony Brook University
Last Modified on24 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Breast Cancer?
Do you have any of these conditions: cancer, breast or Breast Cancer Diagnosis or Breast Cancer or breast carcinoma?
Age >/= 18
Biopsy proven invasive carcinoma of the breast
Clinical T1-T4 invasive carcinoma
Cancer is deemed unresectable with no possibility of future resection or the patient is a poor surgical candidate as determined following evaluation by a surgeon
Women who are not post-menopausal should have a negative urine or serum pregnancy test. Women of childbearing potential must agree to adequate contraception for the duration of study participation
Ability to understand and willingness to sign a written informed consent document
Life expectancy > 6 months
Patient is to be treated at Stony Brook University Hospital

Exclusion Criteria

Women with a known pregnancy, positive serum pregnancy test, or currently breastfeeding as well as women of childbearing potential unwilling or unable to use an acceptable method of birth control (including abstinence or barrier method of birth control) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Breast implant in the breast to be treated with SBRT
Insufficient breast imaging to judge clinical stage
Inability to receive study treatment planning and treatment secondary to body habitus
Inability to understand or unwillingness to sign a written consent document
Life expectancy < 6 months
Children (< 18 years of age)
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with study requirements
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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