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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01247233
First received: October 26, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • rate of local recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To estimate and compare the rate of local recurrence between the experimental and control arms.


Secondary Outcome Measures:
  • Ipsilateral breast recurrence-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To evaluate Ipsilateral breast recurrence-free survival

  • Nodal regional recurrence-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To evaluate nodal regional recurrence-free survival

  • Distant recurrence-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To evaluate distant recurrence-free survival

  • Disease-specific survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To evaluate disease-specific survival

  • Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To evaluate the overall survival

  • Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate Cosmetic results (Patient and Physician evaluations)

  • Quality of Life and Satisfaction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To evaluate the patient quality of life and patient satisfaction

  • Medico-economic study [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation


Estimated Enrollment: 2796
Study Start Date: October 2010
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard or Hypofractionated radiotherapy
Whole breast Radiotherapy, in 6.5 weeks, 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: 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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 ≤ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247233

Contacts
Contact: Jerome LEMONNIER, PhD +33 1 7193 6702 j-lemonnier@unicancer.fr

Locations
France
Centre de radiothérapie du Pays d'Aix Active, not recruiting
Aix-en-Provence, France
Centre de traitement des Hautes energie - Clinique de l'Europe Active, not recruiting
Amiens, France
Centre Hospitalier Universitaire Recruiting
Amiens, France
CHU Jean Minjoz Active, not recruiting
Besancon, France
Centre de Radiothérapie de Bèziers Active, not recruiting
Beziers, France
Institut Bergonié Recruiting
Bordeaux, France
Centre Hospitalier Recruiting
Brive, France
Centre Francois Baclesse Recruiting
Caen, France
CH Chambery Recruiting
Chambery, France
Centre Hospitalier Active, not recruiting
Compiègne, France
Hopital Henri Mondor Recruiting
Creteil, France, 94010
Centre Leonard de Vinci Recruiting
Dechy, France
CHU Michallon Recruiting
Grenoble, France
Hôpital Robert Boulin Active, not recruiting
Libourne, France
Centre Oscar Lambret Recruiting
Lille, France, 59020
CHU Dupuytren Recruiting
Limoges, France
Centre Léon Bérard Recruiting
Lyon, France
Institut Paoli Calmettes Recruiting
Marseille, France
Clinique du Pont de Chaume Recruiting
Montauban, France
Centre Hospitalier intercommunal le Raincy-Montfermeil Active, not recruiting
Montfermeil, France
CRLC Val d'Aurelle Recruiting
Montpellier, France
Centre Hospitalier Recruiting
Montélimar, France
Centre Azuréen de Cancérologie Active, not recruiting
Mougins, France
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France
Centre d'Oncologie de Gentilly Not yet recruiting
Nancy, France
Hopital Americain de Paris Active, not recruiting
Neuilly sur Seine, France
Clinique Hartmann Active, not recruiting
Neuilly sur Seine, France
Centre Antoine Lacassagne Recruiting
Nice, France
Centre de Haute Energie Recruiting
Nice, France
Centre Médical ONCOGARD - Clinique VALDEGOURD Not yet recruiting
Nimes, France
Saint Louis Hospital Recruiting
Paris, France
Groupe Hospitalier Pitié Salpétrière Recruiting
Paris, France
Hopital Tenon Recruiting
Paris, France
Centre Catalan d'Oncologie Recruiting
Perpignan, France
Institut Jean Godinot Recruiting
Reims, France
Centre Eugène Marquis Recruiting
Rennes, France
Centre de radiothérapie Active, not recruiting
Ris Orangis, France
CH de Roanne Not yet recruiting
Roanne, France
Centre Henri Becquerel Recruiting
Rouen, France
Institut de Cancérologie de la Loire Recruiting
Saint Priest en Jarez, France
Centre Paul Stauss Recruiting
Strasbourg, France
Centre Marie Curie Recruiting
Valence, France
Centre Alexis Vautrin Recruiting
Vandoeuvre les Nancy, France
Institut Gustave Roussy Recruiting
Villejuif, France
Sponsors and Collaborators
UNICANCER
Investigators
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
  More Information

No publications provided by UNICANCER

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01247233     History of Changes
Other Study ID Numbers: RTS02-SHARE, 2010-A00243-36, UC-0140/1001, RTS02 / SHARE
Study First Received: October 26, 2010
Last Updated: December 9, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 28, 2014