Symptoms and General Pathology

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Breast Diseases

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Whole breast RT, 50 Gy + "boost" 16 Gy. Whole breast hypofractionated RT without boost, either 40 Gy or 42.5 Gy

APBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed

Whole Breast Irradiation 50 Gy + Boost 16 Gy or Whole breast, either 40 Gy in 15 fractions in 3 weeks or 42.5 Gy in 16 fractions in 3 weeks

Whole Breast Irradiation + Boost or Hypofractionated irradiation

Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.

Accelerated partial breast irradiation

Yazid Belkacemi, MD PhD

Eric Lartigau, MD

Céline Bourgier, MD

The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management.

In this phase III trial, designed in postmenopausal women \>50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.

Following breast conservative surgery, patients will be stratified according to the following prognostic factors using a minimisation technique: age (\<70 vs ≥70), HER2 status (HER2+ vs HER2-), hormonal receptor status (RH+ vs RH-) and lymph node invasion (pN0 vs pN0i+).

Patients will be allocated to receive either standard treatment, hypofractionated treatment or APBI.

Radiation therapy should be started between 4 and 12 weeks after the last surgery.

Patients treated with standard whole breast irradiation will receive a total dose of 50 Gy in 25 fractions, 2 Gy per day, 5 days a week. The boost of 16 Gy will be delivered in 8 fractions for all patients after completion of the 50 Gy, without interruption. All patients will receive one fraction per day, 5 fractions a week.

Patients treated with hypofractionated irradiation will receive a total dose of either 40 Gy (in 15 fractions, 2.66 Gy per day) or 42.5 Gy (in 16 fractions, 2.65 Gy per day) 5 days a week.

Patients treated with APBI will receive a total dose of 40 Gy in 10 fractions, delivered twice a day over a time period of 5-7 days. Each daily dose must be separated by 6 hours.

Patients will be followed at 3 and 6 month after the last dose of irradiation, at 12 months after the date of last surgery and then on a yearly basis during 10 years.

Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer

Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer

Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

To estimate and compare the rate of local recurrence between the experimental and control arms.

To evaluate Ipsilateral breast recurrence-free survival

To evaluate nodal regional recurrence-free survival

To evaluate distant recurrence-free survival

To evaluate rates and type of acute and late toxicities

To evaluate Cosmetic results (Patient and Physician evaluations)

To evaluate the patient quality of life and patient satisfaction

To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer	NCT01247233	Breast Cancer Lumpectomy	Whole Breast Ir... Accelerated par...	50 Years -	UNICANCER
Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer	NCT01247233	Breast Cancer Lumpectomy	Whole Breast Ir... Accelerated par...	50 Years -	UNICANCER

Spots Global Cancer Trial Database for whole breast irradiation + boost or hypofractionated irradiation