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

NCT ID: NCT01247233

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1006 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-27
• Study Completion Date: 2025-10-31

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.

Detailed Description

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.

Conditions

Breast Cancer; Lumpectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard or Hypofractionated radiotherapy

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

Group Type: ACTIVE_COMPARATOR

Whole Breast Irradiation + Boost or Hypofractionated irradiation

Intervention Type: RADIATION

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

Accelerated Partial Breast Irradiation (APBI)

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

Group Type: EXPERIMENTAL

Accelerated partial breast irradiation

Intervention Type: RADIATION

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

Interventions

Whole Breast Irradiation + Boost or Hypofractionated irradiation

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

Intervention Type: RADIATION

Accelerated partial breast irradiation

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

Intervention Type: RADIATION

Other Intervention Names

Standard radiation; APBI

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yazid Belkacemi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor Hospital AP-HP, Créteil, France

Eric Lartigau, MD

Role: PRINCIPAL_INVESTIGATOR

Oscar Lambret Hospital, Lille, France

Céline Bourgier, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Montpellier, Montpellier, France

Locations

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, , France

Centre Leonard de Vinci

Dechy, , France

CHU Michallon

Grenoble, , France

Hôpital Robert Boulin

Libourne, , France

Centre Oscar Lambret

Lille, , 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

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23598908 (View on PubMed)

Other Identifiers

2010-A00243-36

Identifier Type: OTHER

Identifier Source: secondary_id

UC-0140/1001

Identifier Type: OTHER

Identifier Source: secondary_id

RTS02 / SHARE

Identifier Type: OTHER

Identifier Source: secondary_id

RTS02-SHARE

Identifier Type: -

Identifier Source: org_study_id