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

NCT05772390 | Recruiting Phase 2

• 1 other identifier: IRST174.25
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Recurrent

Keywords

Partial re-irradiation; recurrent breast cancer; conservative surgery

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (5)

• in-breast recurrence in the ipsilateral breast

  5 years

• Number of patients free from mastectomy over total number of patients

  5 years

• To evaluate distant-metastasis free survival

  5 years

• Overall survival

  5 years

• Patient satisfaction

  5 years

Study Arms (1)

Partial breast re-irradiation

EXPERIMENTAL

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.

Radiation: Partial breast re-irradiation

Interventions

Partial breast re-irradiation RADIATION

partial breast re-irradiation

Partial breast re-irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant);
• ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence;
• Female, aged \>18 years;
• Life expectancy of greater than 12 months;
• ECOG performance status \<2;
• 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;
• Participant is willing and able to give informed consent for participation in the study;

You may not qualify if:

• Regional recurrences (axillary, supraclavicular);
• Positive histologic margins at resection;
• Metastatic disease;
• Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;
• Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;
• Patients who had chemotherapy within 2 weeks prior to study RT;
• 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 RT for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus);
• 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);
• Inaccessibility for follow-up;

Sponsors & Collaborators

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

Study Sites (1)

UO Radioterapia, IRST IRCCS

Meldola, Forlì Cesena, 47014, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simona Cima

  IRCCS IRST

  STUDY CHAIR

Central Study Contacts

Oriana Nanni

CONTACT

+390543739266; oriana.nanni@irst.emr.it

Bernadette Vertogen

CONTACT

+390544286058; bernadette.vertogen@irst.emr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2032
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)