Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lumpectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated partial breast irradiation | Radiation | — | UNRESOLVED |
| Whole Breast Irradiation + Boost or Hypofractionated irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard or Hypofractionated radiotherapy
- description
- Whole breast RT, 50 Gy + "boost" 16 Gy. Whole breast hypofractionated RT without boost, either 40 Gy or 42.5 Gy
- interventionNames
- Radiation: Whole Breast Irradiation + Boost or Hypofractionated irradiation
- type
- EXPERIMENTAL
- label
- Accelerated Partial Breast Irradiation (APBI)
- description
- APBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed
- interventionNames
- Radiation: Accelerated partial breast irradiation
Primary outcomes (1)
- measure
- rate of local recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBelkacemi 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. PMID 23598908