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 August 2014 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01247233
First received: October 26, 2010
Last updated: August 5, 2014
Last verified: August 2014

October 26, 2010
August 5, 2014
December 2010
October 2019   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01247233 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI)for Breast Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Lumpectomy
  • 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
  • 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
  • Active Comparator: Standard or Hypofractionated radiotherapy
    Whole breast RT, 50Gy + "boost" 16Gy. Whole breast hypofractionated RT without boost, either 40Gy or 42,5Gy.
    Intervention: Radiation: Whole Breast Irradiation + Boost or Hypofractionated irradiation
  • Experimental: Accelerated Partial Breast Irradiation (APBI)
    APBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed .
    Intervention: Radiation: Accelerated partial breast irradiation
Belkacemi Y, Bourgier C, Kramar A, Auzac G, Dumas I, Lacornerie T, Mége 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2796
October 2024
October 2019   (final data collection date for primary outcome measure)

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
Female
50 Years and older
No
Contact: Jerome LEMONNIER, PhD +33 1 7193 6702 j-lemonnier@unicancer.fr
France
 
NCT01247233
RTS02-SHARE, 2010-A00243-36, UC-0140/1001, RTS02 / SHARE
Yes
UNICANCER
UNICANCER
Not Provided
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
UNICANCER
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP