Description:
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.
Clinical Trials /
Intraoperative Radiotherapy After Local Recurrence in Breast Cancer
NCT02386371
Related Conditions:
- Breast Carcinoma
Recruiting Status:
Active, not recruiting
Phase:
N/A
Trial Eligibility
Document
Title
- Brief Title: Intraoperative Radiotherapy After Local Recurrence in Breast Cancer
- Official Title: Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma
Clinical Trial IDs
- ORG STUDY ID: ICM-URC2014/07
- NCT ID: NCT02386371
Conditions
- Breast Carcinoma
Purpose
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.
Detailed Description
Currently, the rate of ipsilateral breast tumor recurrence (IBTR) after breast- conserving
surgery and radiotherapy remains at 10% at 10 years to 15% at 20 years, respectively. IBTR is
an independent predictor of poor survival with a 3 to 4.6 increased risk of cancer-related
death.
In a heterogeneous population, local control remains a major therapeutic challenge for these
relapses, especially those considered of better prognosis, namely occurring late and of low
histological grade. Therapeutic de-escalation is possible for these relapses to avoid a
mutilating and often traumatic mastectomy.
However, this second conservative surgery has a high rate of second local relapse (19 to 50%
at 5 years) due to the absence of a re-irradiation, rendered impossible by the problem of
tolerance of previously irradiated tissues.
Retrospective or prospective studies on partial breast irradiation (PBI) in adjuvant setting
report promising results, both in terms of tolerance (saving healthy tissue) and local
control (74% to 100% at 5 years). Used techniques include brachytherapy, external beam
radiotherapy and intraoperative radiotherapy (IORT).
IORT is now the subject of renewed interest in breast cancer. It has the advantages of
high-precision ballistics on the operated area and of preservation of healthy tissue. To
date, no prospective data, however, have been published in the indication of ipsilateral
breast recurrence.
A prospective, multicenter, single arm Phase II design will evaluate the feasibility of
repeated breast-conserving surgery combined with re- irradiation using IORT after local
recurrence of breast carcinoma.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| surgery and Intra Operative Radiotherapy | Experimental | Surgery : Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams. Intra Operative Radiotherapy (IORT): After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure. |
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)
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 50 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Tolerance of intra operative radiation as assessed by acute and late toxicities |
| Time Frame: | up to 5 years |
| Safety Issue: | |
| Description: |
Secondary Outcome Measures
| Measure: | Cosmetic outcome evaluated by photography |
| Time Frame: | up to 5 years |
| Safety Issue: | |
| Description: | To |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Institut du Cancer de Montpellier - Val d'Aurelle |
Last Updated
August 13, 2021
