Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute toxicity that is not significantly worse than that of a concurrent cohort of patients treated with IMRT randomly assigned to a weekly or daily boost regimen. 2. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed develop late toxicity that is not significantly worse than that of concurrent cohort of patients treated with IMRT randomly assigned to a weekly of daily boost. 3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be achieved in each of the two randomized arms, for either technique tested.

Key facts

Study ID

NCT01591811

Run by

NYU Langone Health

People needed

433

Starts

2012-04-16

Expected to finish

2015-04-30

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pre- or post-menopausal women with Stage 0, I and II breast cancer (Post-menopausal women defined as either (a) at least 2 years without menstrual period or (b) or patients older than 50 with serological evidence of post-menopausal status or (c) hysterectomized patients of any age with FSH confirmation of post-menopausal status)
• Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
• Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5 mm in size do not require nodal assessment)
• At least 2 weeks from last chemotherapy
• Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

You may not qualify if…

• Previous radiation therapy to the ipsilateral breast
• More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation
• Active connective tissue disorders, such as lupus or scleroderma
• Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free > 3 years
• Pregnant or lactating women

Where it is running

• NYU Cancer Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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