Status:
ACTIVE_NOT_RECRUITING
Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer
Lead Sponsor:
UNICANCER
Conditions:
Breast Cancer
Lumpectomy
Eligibility:
FEMALE
50+ years
Phase:
NA
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 4...
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-), hormon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
1006 Patients enrolled
Trial Details
Trial ID
NCT01247233
Start Date
December 27 2010
End Date
October 1 2025
Last Update
May 14 2025
Active Locations (34)
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1
Centre de traitement des Hautes energie - Clinique de l'Europe
Amiens, France
2
Centre Hospitalier Universitaire
Amiens, France
3
Institut Bergonié
Bordeaux, France
4
Centre Hospitalier
Brivé, France