PBI for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment

NCT05663294 | Active Not Recruiting DMC

• 1 other identifier: 3271
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Screening and advances in breast imaging led to a continuous increase of Ductal Carcinoma in situ (DCIS) diagnosis. Whole breast radiotherapy was reported to be effective in reducing the risk of local recurrence in all analyzed patients and tumor characteristics. In order to de-escalate treatment in low and intermediate DCIS, it is possible to investigate the role of partial breast irradiation (PBI). To date, data from available literature supports the hypothesis that PBI is a safe well tolerated therapy that appears to be equivalent to WBI in terms of efficacy and ultimate breast cosmesis.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Local Control rate

  Absence of the occurrence of new lump in the irradiated breast or appearance of skin lesions; it will be divided in inside or outside the treated area, evaluating the localization in the breast. For the evaluation it will be used bilateral mammography.

  5 years

Secondary Outcomes (2)

• toxicities assessed by "Common Terminology Criteria for Adverse Events (CTCAE) v5.0"

  5 years

• The Harvard Scale

  5 years

Study Arms (1)

Partial Breast Irradiation

EXPERIMENTAL

Radiation treatment will be started within 120 days after surgery. The fractionation schedule depends on the policy of the treating center, but is mandatory to use CT-based planning. Both once-daily and twice-daily schedule are allowed. The allowed schedules for external beams radiotherapy are: * 40 Gy in 15 fractions; * 30 Gy in 5 fractions; * 40 Gy or 38.5 in 10 twice-daily fractions (each daily dose must be separated by at least 6 hours). The schedule for brachytherapy are: * 32 Gy in 8 twice-daily fractions for HDR; * 30.3 Gy in 7 twice-daily fractions for HDR; * 50Gy 0.60-0.80 Gy/hour (1 pulse/hour, 24 hours/day) for PDR.

Radiation: external beams radiotherapy; Radiation: brachytherapy

Interventions

external beams radiotherapy RADIATION

External beam radiation therapy uses high doses of radiation to destroy cancer cells and shrink tumors. A large machine aims radiation at the cancer. The allowed schedules for external beams radiotherapy are: * 40 Gy in 15 fractions; * 30 Gy in 5 fractions; * 40 Gy or 38.5 in 10 twice-daily fractions (each daily dose must be separated by at least 6 hours).

Partial Breast Irradiation

brachytherapy RADIATION

Brachytherapy is a form of radiation therapy where a sealed radiation source is placed inside or next to the area requiring treatment. The schedule for brachytherapy are: * 32 Gy in 8 twice-daily fractions for HDR; * 30.3 Gy in 7 twice-daily fractions for HDR; * 50Gy 0.60-0.80 Gy/hour (1 pulse/hour, 24 hours/day) for PDR.

Partial Breast Irradiation

Eligibility Criteria

• Age: 41 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>40
• Pathologically confirmed DCIS:
• low risk (lesions of ≤3 cm diameter, resection margins of at least 2 mm, nuclei grade: G1, G2)
• intermediate risk (lesions of ≤1 cm diameter, resection margins of at least 2 mm, nuclei grade: 3)
• Written informed consent

You may not qualify if:

• Prior thoracic radiation therapy
• Preoperative systemic treatments (i. e., chemotherapy, endocrine therapy);
• Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
• No other cancers in the last 5 years

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Mediolanum Cardio Research: collaborator

Study Sites (1)

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 23, 2022
• Study Start: January 9, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 3, 2025

Record last verified: 2024-10

Locations

IT (1)