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

Primary Purpose

Breast Cancer, Recurrent

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Partial breast re-irradiation
Sponsored by
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Partial re-irradiation, recurrent breast cancer, conservative surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Isolated ipsilateral unifocal breast lesions; Histologically confirmed invasive breast carcinoma or carcinoma in situ; Limited size (< 2 cm) without evidence of skin involvement; Negative histologic margins of resection; Negative axillary lymph nodes; No synchronous distant metastases; Bilateral breast mammogram or MRI within 120 days prior to study entry; 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; ≥ 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: Regional recurrences (axillary, supraclavicular); Positive histologic margins at resection; Metastatic disease; Previous breast Radiotherapy performed with Intraoperative radiotherapy, brachytherapy or previous partial breast treatment; Known pathogenic mutation of BRCA1, BRCA2 or Tumor Protein 53 gene; Patients who had chemotherapy within 2 weeks prior to study Radiotherapy; Participation in another clinical trial with any investigational agents within 30 days prior to study screening; 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; 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

Sites / Locations

  • UO Radioterapia, IRST IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Partial breast re-irradiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment related toxicity
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

in-breast recurrence in the ipsilateral breast
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
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
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
Overall survival is defined as time from registration to date of death or last follow-up
Patient satisfaction
Patients satisfaction is assessed with the Breast-Q questionnaire (from 0 (worst) to 100 (best). Higher scores reflect a better outcome)

Full Information

First Posted
March 6, 2023
Last Updated
April 5, 2023
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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1. Study Identification

Unique Protocol Identification Number
NCT05772390
Brief Title
Partial Breast Re-irradiation in Women in Women With Locally Recurrent Breast Cancer Previously Treated With Conservative Surgery and Whole Breast Irradiation
Acronym
PBReI
Official Title
Partial Breast Re-irradiation in Women With Locally Recurrent Breast Cancer Previously Treated With Conservative Surgery and Whole Breast Irradiation: A Prospective Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Recurrent
Keywords
Partial re-irradiation, recurrent breast cancer, conservative surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partial breast re-irradiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Partial breast re-irradiation
Intervention Description
partial breast re-irradiation
Primary Outcome Measure Information:
Title
Treatment related toxicity
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
in-breast recurrence in the ipsilateral breast
Description
In-breast recurrence is defined histologic evidence of recurrent carcinoma, invasive or noninvasive (excluding lobular carcinoma in situ), in the ipsilateral breast
Time Frame
5 years
Title
Number of patients free from mastectomy over total number of patients
Description
Freedom from mastectomy is calculated from mastectomy failure rates. Failure is a mastectomy of the treated breast performed for any reason
Time Frame
5 years
Title
To evaluate distant-metastasis free survival
Description
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
Time Frame
5 years
Title
Overall survival
Description
Overall survival is defined as time from registration to date of death or last follow-up
Time Frame
5 years
Title
Patient satisfaction
Description
Patients satisfaction is assessed with the Breast-Q questionnaire (from 0 (worst) to 100 (best). Higher scores reflect a better outcome)
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Isolated ipsilateral unifocal breast lesions; Histologically confirmed invasive breast carcinoma or carcinoma in situ; Limited size (< 2 cm) without evidence of skin involvement; Negative histologic margins of resection; Negative axillary lymph nodes; No synchronous distant metastases; Bilateral breast mammogram or MRI within 120 days prior to study entry; 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; ≥ 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: Regional recurrences (axillary, supraclavicular); Positive histologic margins at resection; Metastatic disease; Previous breast Radiotherapy performed with Intraoperative radiotherapy, brachytherapy or previous partial breast treatment; Known pathogenic mutation of BRCA1, BRCA2 or Tumor Protein 53 gene; Patients who had chemotherapy within 2 weeks prior to study Radiotherapy; Participation in another clinical trial with any investigational agents within 30 days prior to study screening; 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; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oriana Nanni
Phone
+390543739266
Email
oriana.nanni@irst.emr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Bernadette Vertogen
Phone
+390544286058
Email
bernadette.vertogen@irst.emr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Cima
Organizational Affiliation
IRCCS IRST
Official's Role
Study Chair
Facility Information:
Facility Name
UO Radioterapia, IRST IRCCS
City
Meldola
State/Province
Forlì Cesena
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Cima
Email
simona.cima@irst.emr.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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