Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI)for Breast Cancer (SHARE)
|ClinicalTrials.gov Identifier: NCT01247233|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2010
Last Update Posted : May 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lumpectomy||Radiation: Whole Breast Irradiation + Boost or Hypofractionated irradiation Radiation: Accelerated partial breast irradiation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1006 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2025|
Active Comparator: Standard or Hypofractionated radiotherapy
Whole breast RT, 50Gy + "boost" 16Gy. Whole breast hypofractionated RT without boost, either 40Gy or 42,5Gy.
Radiation: Whole Breast Irradiation + Boost or Hypofractionated irradiation
Whole Breast Irradiation 50Gy + Boost 16 Gy or Whole breast, either 40Gy in 15 fractions in 3 weeks or 42,5Gy in 16 fractions in 3 weeks
Other Name: Standard radiation
Experimental: Accelerated Partial Breast Irradiation (APBI)
APBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed .
Radiation: Accelerated partial breast irradiation
Tumor bed 40Gy in 10 fractions, 2 fractions of 4Gy per day in 5 to 7 days.
Other Name: APBI
- rate of local recurrence [ Time Frame: 5 years ]To estimate and compare the rate of local recurrence between the experimental and control arms.
- Ipsilateral breast recurrence-free survival [ Time Frame: 10 years ]To evaluate Ipsilateral breast recurrence-free survival
- Nodal regional recurrence-free survival [ Time Frame: 10 years ]To evaluate nodal regional recurrence-free survival
- Distant recurrence-free survival [ Time Frame: 10 years ]To evaluate distant recurrence-free survival
- Disease-specific survival [ Time Frame: 10 years ]To evaluate disease-specific survival
- Overall survival [ Time Frame: 10 years ]To evaluate the overall survival
- Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects) [ Time Frame: 10 years ]To evaluate rates and type of acute and late toxicities
- Cosmetic: comparison of the cosmetic result (according to both the physician and the patient) [ Time Frame: 10 years ]To evaluate Cosmetic results (Patient and Physician evaluations)
- Quality of Life and Satisfaction [ Time Frame: 10 years ]To evaluate the patient quality of life and patient satisfaction
- Medico-economic study [ Time Frame: 3 years ]To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247233
|Centre de traitement des Hautes energie - Clinique de l'Europe|
|Centre Hospitalier Universitaire|
|Centre Francois Baclesse|
|Hopital Henri Mondor|
|Creteil, France, 94010|
|Centre Leonard de Vinci|
|Hôpital Robert Boulin|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Léon Bérard|
|Institut Paoli Calmettes|
|Clinique du Pont de Chaume|
|CRLC Val d'Aurelle|
|Centre Hospitalier de Mulhouse|
|Centre d'Oncologie de Gentilly|
|Neuilly sur Seine, France|
|Centre de Haute Energie|
|Groupe Hospitalier Pitié Salpétrière|
|Saint Louis Hospital|
|Centre Catalan d'Oncologie|
|Institut Jean Godinot|
|Centre Eugène Marquis|
|CH de Roanne|
|Centre Henri Becquerel|
|Institut de Cancérologie de la Loire|
|Saint Priest en Jarez, France|
|Centre Paul Stauss|
|Centre Marie Curie|
|Centre Alexis Vautrin|
|Vandoeuvre les Nancy, France|
|Institut Gustave Roussy|
|Principal Investigator:||Yazid Belkacemi, MD PhD||Henri Mondor Hospital AP-HP, Créteil, France|
|Principal Investigator:||Eric Lartigau, MD||Oscar Lambret Hospital, Lille, France|
|Principal Investigator:||Céline Bourgier, MD||Institut de Cancérologie de Montpellier, Montpellier, France|