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BRE008-12 Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Patients with

Stage II/III, Loco-Regional, Non-Metastatic Breast Cancer Requiring Whole Breast or Chest Wall

Irradiation with Lymph Node Irradiation

R

E

G

I

S

T

E

R

BREAST CONSERVING THERAPY:

Whole breast and regional lymph nodes (axilla levels I-III, supraclavicular*):

45 - 50.4 Gy (RBE) in 25 - 28 fractions of 1.8 Gy (RBE) per fraction

and

Internal mammary node chain (IMC) for stage III patients*:

45 - 50.4 Gy (RBE) in 25 - 28 fractions of 1.8 Gy (RBE).

+

Lumpectomy tumor bed boost to a total cumulative dose of

61.2 - 66.6 Gy (RBE) in 1.8 Gy (RBE) per fraction

MASTECTOMY:

Chest wall and regional lymph nodes (axilla levels I-III, supraclavicular*):

45 -50.4 Gy (RBE) in 25 - 28 fractions of 1.8 Gy (RBE).

and

Internal mammary node chain (IMC), for stage III patients*:

45 - 50.4 Gy (RBE) in 25 - 28 fractions of 1.8 Gy (RBE).

+

Chest wall scar boost (optional): for a total cumulative dose of 61.2 Gy (RBE)

in 1.8 Gy (RBE) per fraction.

PI’s: E. Hug, M. Fagundes, M. Pankuch, N. Schreuder et al. – opened 2/2013.

ENDPOINTS:

Reducti n of incidence f major cardiac morbidity

Maintaining comparable Local control and Survival at 5 years

Cosmesis

Quality of Life