Intraoperative Radiotherapy After Local Recurrence in Breast Cancer

NCT ID: NCT02386371

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2023-09-18

Brief 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.

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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgery and Intra Operative Radiotherapy

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.

Group Type: EXPERIMENTAL

tumorectomy

Intervention Type: PROCEDURE

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

Intervention Type: RADIATION

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

Interventions

tumorectomy

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.

Intervention Type: PROCEDURE

Intra Operative Radiotherapy

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

Intervention Type: RADIATION

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LEMANSKI Claire

Role: STUDY_CHAIR

Institut régional du Cancer - Val d'Aurelle

Locations

Institut Bergonié

Bordeaux, , France

Chu Brest

Brest, , France

Centre George Francois Leclerc

Dijon, , France

Centre Léon Bérard

Lyon, , France

CHU La TIMONE

Marseille, , France

Institut Paoli Calmette

Marseille, , France

ICM

Montpellier, , France

Institut de Cancérologie de l'Ouest

Nantes, , France

Countries

France

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ICM-URC2014/07

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Identifier Source: org_study_id