Breast Cancer | Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI)for Breast Cancer
Breast Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Radiation:Whole Breast Irradiation + Boost or Hypofractionated irradiationWhole 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
Radiation:Accelerated partial breast irradiationTumor bed 40Gy in 10 fractions, 2 fractions of 4Gy per day in 5 to 7 days.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Standard or Hypofractionated radiotherapyWhole breast RT, 50Gy + "boost" 16Gy. Whole breast hypofractionated RT without boost, either 40Gy or 42,5Gy.
Accelerated Partial Breast Irradiation (APBI)APBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed .
Active, not recruiting
Start Date: December 2010
Completed Date: October 2025
Phase: Phase 3
Primary Outcome: rate of local recurrence
Secondary Outcome: Ipsilateral breast recurrence-free survival
Study sponsors, principal investigator, and references
Principal Investigator: Yazid Belkacemi, MD PhD
Lead Sponsor: UNICANCER