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Breast CancerSHARENCT01247233

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

A study testing Whole Breast Irradiation + Boost or Hypofractionated irradiation and Accelerated partial breast irradiation in people with Breast Cancer and Lumpectomy, run by UNICANCER at 34 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Cancer, Lumpectomy
What is being tested?
Whole Breast Irradiation + Boost or Hypofractionated irradiation and Accelerated partial breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,006 participants
Where
34 sitesFrance
Study dates
27 Dec 2010to Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

France34 sites

  • Centre de traitement des Hautes energie - Clinique de l'Europe

    Amiens

  • Centre Hospitalier Universitaire

    Amiens

  • Institut Bergonié

    Bordeaux

  • Centre Hospitalier

    Brivé

  • Centre Francois Baclesse

    Caen

  • CH Chambery

    Chambéry

  • Hopital Henri Mondor

    Créteil, 94010

  • Centre Leonard de Vinci

    Dechy

  • CHU Michallon

    Grenoble

  • Hôpital Robert Boulin

    Libourne

  • Centre Oscar Lambret

    Lille, 59020

  • CHU Dupuytren

    Limoges

  • Centre Léon Bérard

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • Clinique du Pont de Chaume

    Montauban

  • Centre Hospitalier

    Montélimar

  • CRLC Val d'Aurelle

    Montpellier

  • Centre Hospitalier de Mulhouse

    Mulhouse

  • Centre d'Oncologie de Gentilly

    Nancy

  • Clinique Hartmann

    Neuilly-sur-Seine

  • Centre de Haute Energie

    Nice

  • Groupe Hospitalier Pitié Salpétrière

    Paris

  • Hopital Tenon

    Paris

  • Saint Louis Hospital

    Paris

  • Centre Catalan d'Oncologie

    Perpignan

  • Institut Jean Godinot

    Reims

  • Centre Eugène Marquis

    Rennes

  • CH de Roanne

    Roanne

  • Centre Henri Becquerel

    Rouen

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez

  • Centre Paul Stauss

    Strasbourg

  • Centre Marie Curie

    Valence

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Whole Breast Irradiation + Boost or Hypofractionated irradiation, Accelerated partial breast irradiation
Keywords
breast cancer, Accelerated Partial Breast Irradiation, invasive cancer, Hypofractionated Irradiation, Lumpectomy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole Breast Irradiation + Boost or Hypofractionated irradiationRadiation

    Also called Standard 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 irradiationRadiation

    Also called APBI

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

Study groups in NCT01247233
Study groupRoleWhat they receive
Standard or Hypofractionated radiotherapyActive comparatorWhole breast RT, 50 Gy + "boost" 16 Gy. Whole breast hypofractionated RT without boost, either 40 Gy or 42.5 Gy
Receives: Radiation: Whole Breast Irradiation + Boost or Hypofractionated irradiation
Accelerated Partial Breast Irradiation (APBI)ExperimentalAPBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed
Receives: Radiation: Accelerated partial breast irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of local recurrence

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

    Measured: 5 years

Secondary outcomes (9)

  1. Ipsilateral breast recurrence-free survival

    To evaluate Ipsilateral breast recurrence-free survival

    Measured: 10 years

  2. Nodal regional recurrence-free survival

    To evaluate nodal regional recurrence-free survival

    Measured: 10 years

  3. Distant recurrence-free survival

    To evaluate distant recurrence-free survival

    Measured: 10 years

  4. Disease-specific survival

    To evaluate disease-specific survival

    Measured: 10 years

  5. Overall survival

    To evaluate the overall survival

    Measured: 10 years

  6. Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects)

    To evaluate rates and type of acute and late toxicities

    Measured: 10 years

  7. Cosmetic: comparison of the cosmetic result (according to both the physician and the patient)

    To evaluate Cosmetic results (Patient and Physician evaluations)

    Measured: 10 years

  8. Quality of Life and Satisfaction

    To evaluate the patient quality of life and patient satisfaction

    Measured: 10 years

  9. Medico-economic study

    To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2010 (estimated)
  2. Study start27 Dec 2010
  3. Primary completion7 Dec 2020
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,006 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01247233
Sponsor's protocol ID
RTS02-SHARE
Other IDs
2010-A00243-36, UC-0140/1001, RTS02 / SHARE
Acronym
SHARE
Status last verified
May 2025
First submitted
26 Oct 2010
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 23598908

Questions about this trial

What is this clinical trial studying?

A study testing Whole Breast Irradiation + Boost or Hypofractionated irradiation and Accelerated partial breast irradiation in people with Breast Cancer and Lumpectomy, run by UNICANCER at 34 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of local recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01247233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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