Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer
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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
4 other identifiers
interventional
1,006
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Dec 2010
Longer than P75 for not_applicable breast-cancer
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedStudy Start
First participant enrolled
December 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedMay 14, 2025
May 1, 2025
10 years
October 26, 2010
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of local recurrence
To estimate and compare the rate of local recurrence between the experimental and control arms.
5 years
Secondary Outcomes (9)
Ipsilateral breast recurrence-free survival
10 years
Nodal regional recurrence-free survival
10 years
Distant recurrence-free survival
10 years
Disease-specific survival
10 years
Overall survival
10 years
- +4 more secondary outcomes
Study Arms (2)
Standard or Hypofractionated radiotherapy
ACTIVE COMPARATORWhole breast RT, 50 Gy + "boost" 16 Gy. Whole breast hypofractionated RT without boost, either 40 Gy or 42.5 Gy
Accelerated Partial Breast Irradiation (APBI)
EXPERIMENTALAPBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed
Interventions
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
Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.
Eligibility Criteria
You may qualify if:
- Women aged ≥50 years
- Menopausal status confirmed
- Pathology confirmation of invasive carcinoma (all types)
- Complete tumor removal and conservative surgery
- Pathologic tumor size of invasive carcinoma ≤2 cm (including the in situ component) pT1
- All histopathologic grades
- Clear lateral margins for the invasive and in situ disease (\>2 mm)
- pN0 or pN(i+)
- No metastasis
- Radiotherapy should be started more than 4 weeks and less than 12 weeks after last surgery
- Surgical clips (4 to 5 clips in the tumor bed)
- No prior breast or mediastinal radiotherapy
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Information to the patient and signed informed consent
You may not qualify if:
- Multifocal invasive ductal carcinoma defined as the presence of at least two distinct tumors that are separated by normal tissue or when the distance between the two lesions does not permit conservative surgery
- Bilateral breast cancer
- No or less than 4 surgical clips in the tumor bed
- Nodal involvement : pN1 (including micrometastasis, mi+), pN2, pN3
- Metastatic disease
- internal mammary node involvement or supraclavicular lymph node involvement
- Indication of chemotherapy or trastuzumab
- Involved or close lateral margins for the invasive and /or in situ components (\<2 mm) AND impossibility to re-operate or impossible to perform another conservative surgery
- Patients with known BRCA1 or BRCA2 mutations
- Previous mammoplasty
- Previous homolateral breast and/or mediastinal irradiation
- Previous invasive cancer (except basocellular epithelioma or in situ carcinoma of the cervix)
- No geographical, social or psychologic reasons that would prevent study follow
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (34)
Centre de traitement des Hautes energie - Clinique de l'Europe
Amiens, France
Centre Hospitalier Universitaire
Amiens, France
Institut Bergonié
Bordeaux, France
Centre Hospitalier
Brivé, France
Centre Francois Baclesse
Caen, France
CH Chambery
Chambéry, France
Hopital Henri Mondor
Créteil, 94010, France
Centre Leonard de Vinci
Dechy, France
CHU Michallon
Grenoble, France
Hôpital Robert Boulin
Libourne, France
Centre Oscar Lambret
Lille, 59020, France
CHU Dupuytren
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Clinique du Pont de Chaume
Montauban, France
Centre Hospitalier
Montélimar, France
CRLC Val d'Aurelle
Montpellier, France
Centre Hospitalier de Mulhouse
Mulhouse, France
Centre d'Oncologie de Gentilly
Nancy, France
Clinique Hartmann
Neuilly-sur-Seine, France
Centre de Haute Energie
Nice, France
Groupe Hospitalier Pitié Salpétrière
Paris, France
Hopital Tenon
Paris, France
Saint Louis Hospital
Paris, France
Centre Catalan d'Oncologie
Perpignan, France
Institut Jean Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
CH de Roanne
Roanne, France
Centre Henri Becquerel
Rouen, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France
Centre Paul Stauss
Strasbourg, France
Centre Marie Curie
Valence, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Related Publications (1)
Belkacemi Y, Bourgier C, Kramar A, Auzac G, Dumas I, Lacornerie T, Mege JP, Mijonnet S, Lemonnier J, Lartigau E. SHARE: a French multicenter phase III trial comparing accelerated partial irradiation versus standard or hypofractionated whole breast irradiation in breast cancer patients at low risk of local recurrence. Clin Adv Hematol Oncol. 2013 Feb;11(2):76-83.
PMID: 23598908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2010
First Posted
November 24, 2010
Study Start
December 27, 2010
Primary Completion
December 7, 2020
Study Completion
October 1, 2025
Last Updated
May 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
- Access Criteria
- The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
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.