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

Phase 2

Recruiting

• Conditions: Breast Cancer; Recurrent
• Interventions: Radiation: Partial breast re-irradiation

• Registration Number: NCT05772390
• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Study Start: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07
• Primary Completion: 2027-03
• Study Completion: 2032-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 68

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) Positron Emission Tomography -Computerized Tomography scan or Computerized Tomography scan of the chest, abdomen, and pelvis, and bone scan;

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. Eastern Cooperative Oncology Group (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 Radiotherapy performed with Intraoperative radiotherapy, brachytherapy or previous partial breast treatment;

5. Known pathogenic mutation of BRCA1, BRCA2 or Tumor Protein 53 gene;

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

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 radiotherapy 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partial breast re-irradiation	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.

Primary Outcome Measures

Name	Time	Method
Treatment related toxicity	12 months	determine the toxicity of partial breast re-irradiation (PBrI) as rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain Adverse Events, accordin to Common Terminology Criteria for Adverse Events scale 5.0 (Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE) up to 1 year from completion of radiation treatment

Secondary Outcome Measures

Name	Time	Method
in-breast recurrence in the ipsilateral breast	5 years	In-breast recurrence is defined histologic evidence of recurrent carcinoma, invasive or noninvasive (excluding lobular carcinoma in situ), in the ipsilateral breast
Number of patients free from mastectomy over total number of patients	5 years	Freedom from mastectomy is calculated from mastectomy failure rates. Failure is a mastectomy of the treated breast performed for any reason
To evaluate distant-metastasis free survival	5 years	Distant metastasis-free survival is defined as time from registration to the appearance of a distant metastasis confirmed radiographically and/or pathologically or death from any cause
Overall survival	5 years	Overall survival is defined as time from registration to date of death or last follow-up
Patient satisfaction	5 years	Patients satisfaction is assessed with the Breast-Q questionnaire (from 0 (worst) to 100 (best). Higher scores reflect a better outcome)

Trial Locations

Locations (1)

UO Radioterapia, IRST IRCCS; 🇮🇹 Meldola, Forlì Cesena, Italy