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

Primary Purpose

Breast Cancer, Lumpectomy

Status
Active
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Whole Breast Irradiation + Boost or Hypofractionated irradiation
Accelerated partial breast irradiation
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, Accelerated Partial Breast Irradiation, invasive cancer, Hypofractionated Irradiation, Lumpectomy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de traitement des Hautes energie - Clinique de l'Europe
  • Centre Hospitalier Universitaire
  • Institut Bergonié
  • Centre Hospitalier
  • Centre Francois Baclesse
  • CH Chambery
  • Hopital Henri Mondor
  • Centre Leonard de Vinci
  • CHU Michallon
  • Hôpital Robert Boulin
  • Centre Oscar Lambret
  • CHU Dupuytren
  • Centre Léon Bérard
  • Institut Paoli Calmettes
  • Clinique du Pont de Chaume
  • CRLC Val d'Aurelle
  • Centre Hospitalier
  • Centre Hospitalier de Mulhouse
  • Centre d'Oncologie de Gentilly
  • Clinique Hartmann
  • Centre de Haute Energie
  • Groupe Hospitalier Pitié Salpétrière
  • Hopital Tenon
  • 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
  • Centre Paul Stauss
  • Centre Marie Curie
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard or Hypofractionated radiotherapy

Accelerated Partial Breast Irradiation (APBI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

rate of local recurrence
To estimate and compare the rate of local recurrence between the experimental and control arms.

Secondary Outcome Measures

Ipsilateral breast recurrence-free survival
To evaluate Ipsilateral breast recurrence-free survival
Nodal regional recurrence-free survival
To evaluate nodal regional recurrence-free survival
Distant recurrence-free survival
To evaluate distant recurrence-free survival
Disease-specific survival
To evaluate disease-specific survival
Overall survival
To evaluate the overall survival
Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects)
To evaluate rates and type of acute and late toxicities
Cosmetic: comparison of the cosmetic result (according to both the physician and the patient)
To evaluate Cosmetic results (Patient and Physician evaluations)
Quality of Life and Satisfaction
To evaluate the patient quality of life and patient satisfaction
Medico-economic study
To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation

Full Information

First Posted
October 26, 2010
Last Updated
February 28, 2023
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT01247233
Brief Title
Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer
Acronym
SHARE
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 Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2010 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lumpectomy
Keywords
breast cancer, Accelerated Partial Breast Irradiation, invasive cancer, Hypofractionated Irradiation, Lumpectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1006 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard or Hypofractionated radiotherapy
Arm Type
Active Comparator
Arm Description
Whole breast RT, 50 Gy + "boost" 16 Gy. Whole breast hypofractionated RT without boost, either 40 Gy or 42.5 Gy
Arm Title
Accelerated Partial Breast Irradiation (APBI)
Arm Type
Experimental
Arm Description
APBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed
Intervention Type
Radiation
Intervention Name(s)
Whole Breast Irradiation + Boost or Hypofractionated irradiation
Other Intervention Name(s)
Standard radiation
Intervention Description
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
Intervention Name(s)
Accelerated partial breast irradiation
Other Intervention Name(s)
APBI
Intervention Description
Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.
Primary Outcome Measure Information:
Title
rate of local recurrence
Description
To estimate and compare the rate of local recurrence between the experimental and control arms.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Ipsilateral breast recurrence-free survival
Description
To evaluate Ipsilateral breast recurrence-free survival
Time Frame
10 years
Title
Nodal regional recurrence-free survival
Description
To evaluate nodal regional recurrence-free survival
Time Frame
10 years
Title
Distant recurrence-free survival
Description
To evaluate distant recurrence-free survival
Time Frame
10 years
Title
Disease-specific survival
Description
To evaluate disease-specific survival
Time Frame
10 years
Title
Overall survival
Description
To evaluate the overall survival
Time Frame
10 years
Title
Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects)
Description
To evaluate rates and type of acute and late toxicities
Time Frame
10 years
Title
Cosmetic: comparison of the cosmetic result (according to both the physician and the patient)
Description
To evaluate Cosmetic results (Patient and Physician evaluations)
Time Frame
10 years
Title
Quality of Life and Satisfaction
Description
To evaluate the patient quality of life and patient satisfaction
Time Frame
10 years
Title
Medico-economic study
Description
To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yazid Belkacemi, MD PhD
Organizational Affiliation
Henri Mondor Hospital AP-HP, Créteil, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Lartigau, MD
Organizational Affiliation
Oscar Lambret Hospital, Lille, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Céline Bourgier, MD
Organizational Affiliation
Institut de Cancérologie de Montpellier, Montpellier, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de traitement des Hautes energie - Clinique de l'Europe
City
Amiens
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Amiens
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
Centre Hospitalier
City
Brive
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
Country
France
Facility Name
CH Chambery
City
Chambery
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Leonard de Vinci
City
Dechy
Country
France
Facility Name
CHU Michallon
City
Grenoble
Country
France
Facility Name
Hôpital Robert Boulin
City
Libourne
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHU Dupuytren
City
Limoges
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Clinique du Pont de Chaume
City
Montauban
Country
France
Facility Name
CRLC Val d'Aurelle
City
Montpellier
Country
France
Facility Name
Centre Hospitalier
City
Montélimar
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
Country
France
Facility Name
Centre d'Oncologie de Gentilly
City
Nancy
Country
France
Facility Name
Clinique Hartmann
City
Neuilly sur Seine
Country
France
Facility Name
Centre de Haute Energie
City
Nice
Country
France
Facility Name
Groupe Hospitalier Pitié Salpétrière
City
Paris
Country
France
Facility Name
Hopital Tenon
City
Paris
Country
France
Facility Name
Saint Louis Hospital
City
Paris
Country
France
Facility Name
Centre Catalan d'Oncologie
City
Perpignan
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
CH de Roanne
City
Roanne
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint Priest en Jarez
Country
France
Facility Name
Centre Paul Stauss
City
Strasbourg
Country
France
Facility Name
Centre Marie Curie
City
Valence
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre les Nancy
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
23598908
Citation
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.
Results Reference
derived

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

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