N/A
N=66
Intraoperative Radiotherapy After Local Recurrence in Breast Cancer
Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02386371 ↗Enrolled (actual)
66
Serious AEs
5.1%
Results posted
Feb 2025
Primary outcome: Primary: The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer — 34; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tumorectomy (Procedure); Intra Operative Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer |
34; 19 | — |
| SECONDARY Rate of Early and Late Toxicities |
4; 18; 27; 10; 0; 12 | — |
| SECONDARY Local Relapse-free Survival |
2; 51 | — |
| SECONDARY Metastasis Relapse-free Survival |
1; 52 | — |
| SECONDARY Disease-free Survival. |
9; 44 | — |
| SECONDARY Overall Survival |
6 | — |
| SECONDARY Free Interval Without Mastectomy. |
3 | — |
Summary
The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.
Eligibility Criteria
Inclusion Criteria
- Histologically proven non-lobular invasive breast recurrence
- Time from whole breast radiation following the initial lumpectomy >5 years
- Unifocal tumor
- Recurrent tumor size ≤ 2 cm
- Adequate breast size for a second breast-conserving surgery with acceptable cosmetic result
- Bilateral breast mammogram within 90 days prior to study entry
- Breast MRI within 90 days prior to study entry
- Histological grade I-II
- Estrogen-receptor-positive tumor (ER+)
- Cerb2-negative tumor
- N0
- M0
- Prior radiotherapy delivered within a standard fractionation schedule
- Performance status (ECOG) 0-1
- Women ≥ 50 years -Absence of any psychological, familial, sociological, or geographical conditions with a potential to hamper compliance with the study and follow- up schedule
- Affiliated to the French Health Insurance regimen
- Written and signed informed consent form.
Exclusion Criteria
- Multifocal and/or multicenter recurrence
- Lobular carcinoma
- Estrogen-receptor-negative tumor (ER-)
- Cerb2 (her2) overexpressed - breast cancer
- Extensive intraductal component (EIC) on biopsy
- Lymph vessel invasion on biopsy
- N1-3 status: Regional cytological or histologically proven node recurrence
- M1 status: Metastatic disease
- cT4 (Skin or muscle involvement) or Paget's disease of the nipple
- Prior radiotherapy delivered within an accelerated or hypo-fraction schedule
- Prior malignancy other than non-melanoma skin cancer unless the patient has been disease free for at least 5 years
- Patients with a small breast volume, technically unsatisfactory for a second conservative surgery or intraoperative breast irradiation.
- Preoperative chemotherapy or hormone therapy for local relapse
- Connective tissue disease or scleroderma, contraindicating radiotherapy
- Known BRCA1/2 gene mutation (genetic testing is not required)
Data sourced from ClinicalTrials.gov (NCT02386371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.