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Young boost phase III trial:
Radiation dose intensity study in breast cancer in young
women: a randomized phase III trial of additional dose to the tumor bed: closed
Main objective:
is to compare the effect of a high boost dose (26 Gy) with a low boost dose (16 Gy) in
breast conserving therapy, on the local recurrence rate.
Secondary objective:
to compare the effect of the high boost dose (26 Gy) with a low boost dose (16 Gy)
in breast conserving therapy, on the cosmesis and possible sequelae.
Additional objectives:
A. To test the genotypic and phenotypic profiles of breast tumors in young patients with invasive
breast cancer, and its relation to:
a. Local recurrence after BCT
b. Lymph node metastases
c. Distant metastases and survival
d. Radiosensitivity
e. Age
B. To determine whether improved genotypic and phenotypic profiles can be determined
related to the endpoints mentioned previously.
End-points
Primary endpoint: Local control at 10 year
Secondary endpoint: Cosmetic outcome
Expected Results in ….