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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01247233
Recruitment Status : Active, not recruiting
First Posted : November 24, 2010
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Lumpectomy Radiation: Whole Breast Irradiation + Boost or Hypofractionated irradiation Radiation: Accelerated partial breast irradiation Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. rate of local recurrence [ Time Frame: 5 years ]
    To estimate and compare the rate of local recurrence between the experimental and control arms.

Secondary Outcome Measures :
  1. Ipsilateral breast recurrence-free survival [ Time Frame: 10 years ]
    To evaluate Ipsilateral breast recurrence-free survival

  2. Nodal regional recurrence-free survival [ Time Frame: 10 years ]
    To evaluate nodal regional recurrence-free survival

  3. Distant recurrence-free survival [ Time Frame: 10 years ]
    To evaluate distant recurrence-free survival

  4. Disease-specific survival [ Time Frame: 10 years ]
    To evaluate disease-specific survival

  5. Overall survival [ Time Frame: 10 years ]
    To evaluate the overall survival

  6. 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

  7. 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)

  8. Quality of Life and Satisfaction [ Time Frame: 10 years ]
    To evaluate the patient quality of life and patient satisfaction

  9. Medico-economic study [ Time Frame: 3 years ]
    To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 ≤ 2cm (including the in situ component) pT1
  • All histopathologic grades
  • Clear lateral margins for the invasive and in situ disease (> 2mm)
  • 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
  • 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 (< 2mm) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01247233

Centre de traitement des Hautes energie - Clinique de l'Europe
Amiens, France
Centre Hospitalier Universitaire
Amiens, France
Institut Bergonié
Bordeaux, France
Centre Hospitalier
Brive, France
Centre Francois Baclesse
Caen, France
CH Chambery
Chambery, France
Hopital Henri Mondor
Creteil, France, 94010
Centre Leonard de Vinci
Dechy, France
CHU Michallon
Grenoble, France
Hôpital Robert Boulin
Libourne, France
Centre Oscar Lambret
Lille, France, 59020
CHU Dupuytren
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Clinique du Pont de Chaume
Montauban, France
CRLC Val d'Aurelle
Montpellier, France
Centre Hospitalier
Montélimar, 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
Vandoeuvre les Nancy, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: UNICANCER Identifier: NCT01247233     History of Changes
Other Study ID Numbers: RTS02-SHARE
2010-A00243-36 ( Other Identifier: ID-RCB )
UC-0140/1001 ( Other Identifier: UNICANCER )
RTS02 / SHARE ( Other Identifier: UNICANCER )
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by UNICANCER:
breast cancer
Accelerated Partial Breast Irradiation
invasive cancer
Hypofractionated Irradiation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases