Study of Stereotactic Radiotherapy for Breast Cancer

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    40
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 28 January 2021
carcinoma
HER2
erbb2
sentinel node
breast-conserving surgery
ductal carcinoma
sentinel lymph node biopsy

Summary

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

Description

This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Stereotactic Body Radiation SBRT
Clinical Study IdentifierNCT03043794
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 50 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: breast carcinoma or Breast Cancer or cancer, breast or Breast Cancer Diagnosis?
Do you have any of these conditions: breast carcinoma or cancer, breast or Breast Cancer Diagnosis or Breast Cancer?
Do you have any of these conditions: Breast Cancer Diagnosis or cancer, breast or Breast Cancer or breast carcinoma?
Female sex
Age > or = to 50 years of age
Invasive ductal carcinoma
Clinically and radiographically T1 tumor
Clinically node negative
Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
Planning breast conserving surgery including sentinel node biopsy
% expression of ER and/or PR
HER2- using the current College of American Pathologists guidelines
Post-menopausal
Willing and able to provide informed consent

Exclusion Criteria

Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
Pure DCIS without invasive cancer
Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
Positive pregnancy test
Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement
Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
Planning mastectomy
Unable to tolerate prone positioning
Clear my responses

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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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