Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation

NCT ID: NCT05772390

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2032-03-31

Brief Summary

A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer

Detailed Description

Breast cancer is the leading type of cancer in women worldwide. Although advances in treatment have led to an overall reduction in breast cancer mortality, survivors continue to have an ongoing risk of disease recurrence. For women who experience breast recurrence, mastectomy has historically been the only treatment approach offered. However, it has been associated with negative health outcomes, including reduced quality of life, depression and anxiety, and impaired sexual functioning. As a result, there is increasing interest to identify treatment options that include breast preservation. Breast-conserving surgery followed by re-irradiation with partial breast irradiation has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation.

Conditions

Breast Cancer; Recurrent

Study Design

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

Study Groups

Partial breast re-irradiation

partial breast re-irradiation in patients with local recurrence of breast cancer, previously treated with breast conservative surgery and whole breast radiotherapy. A total dose of 35 Gy in 10 daily fractions, 5 fractions per week, will be prescribed.

Group Type: EXPERIMENTAL

Partial breast re-irradiation

Intervention Type: RADIATION

partial breast re-irradiation

Interventions

Partial breast re-irradiation

partial breast re-irradiation

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Isolated ipsilateral unifocal breast lesions;

2. Histologically confirmed invasive breast carcinoma or carcinoma in situ;

3. Limited size (< 2 cm) without evidence of skin involvement;

4. Negative histologic margins of resection;

5. Negative axillary lymph nodes;

6. No synchronous distant metastases;

7. Bilateral breast mammogram or MRI within 120 days prior to study entry;

8. For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant);

9. ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence;

10. Female, aged >18 years;

11. Life expectancy of greater than 12 months;

12. ECOG performance status <2;

13. Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter;

14. Participant is willing and able to give informed consent for participation in the study;

Exclusion Criteria

1. Regional recurrences (axillary, supraclavicular);

2. Positive histologic margins at resection;

3. Metastatic disease;

4. Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;

5. Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;

6. Patients who had chemotherapy within 2 weeks prior to study RT;

7. Participation in another clinical trial with any investigational agents within 30 days prior to study screening;

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;

9. Significant comorbidity precluding RT for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus);

10. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix, endometrium or colon);

11. Inaccessibility for follow-up;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simona Cima

Role: STUDY_CHAIR

IRCCS IRST

Locations

UO Radioterapia, IRST IRCCS

Meldola, Forlì Cesena, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Oriana Nanni

Role: CONTACT

oriana.nanni@irst.emr.it

+390543739266

Bernadette Vertogen

Role: CONTACT

bernadette.vertogen@irst.emr.it

+390544286058

Facility Contacts

Simona Cima

Role: primary

simona.cima@irst.emr.it

Other Identifiers

IRST174.25

Identifier Type: -

Identifier Source: org_study_id