High Five (HiFi) Accelerated Partial Breast Irradiation Study

NCT05142202 | Unknown

• 1 other identifier: HiFi-APBI
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

To establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in selected women with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.

Conditions

Breast Cancer

Keywords

breast cancer; breast-conserving surgery; brachytherapy; High Five; APBI

Outcome Measures

Primary Outcomes (2)

• Adjuvant treatment - the early toxicity incidence

  The early toxicity incidence (radiodermatitis, hematoma, breast infection, intraoperative breast damage, breast pain) according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE) in 3 months frame.

  Up to 48 months

• Adjuvant treatment - the late toxicity incidence

  The late toxicity incidence (skin, subcutaneous tissue) according to the RTOG/EORTC Late Radiation Morbidity Scoring Schema in 24 months frame.

  up to 48 months

Study Arms (1)

Doubly Accelerated Partial Breast Irradiation after Breast-Conserving Surgery

EXPERIMENTAL

All recruited participants will be treated with adjuvant to breast-conserving surgery accelerated partial breast irradiation with multicatheter interstitial brachytherapy technique and prescribed five times 5,4 Gy delivered in 3 consecutive days (6 hours minimum gap between the fractions). Treatment starts not later than 12 weeks after surgery (optimally 4-8 weeks), after wound healing, and obtaining the final pathological report with full immunohistochemistry and proper risk group assignment. The control group consists of standard adjuvant APBI with multicatheter interstitial brachytherapy technique 8 x 4 Gy in 5 consecutive days or 7 x 4,3 Gy in 4 consecutive days (6 hours minimum gap between the fractions).

Radiation: Breast Irradiation after Breast-Conserving Surgery

Interventions

Breast Irradiation after Breast-Conserving Surgery RADIATION

All recruited participants will be treated with adjuvant to breast-conserving surgery accelerated partial breast irradiation with multicatheter interstitial brachytherapy technique and prescribed five times 5,4 Gy delivered in 3 consecutive days (6 hours minimum gap between the fractions). Treatment starts not later than 12 weeks after surgery (optimally 4-8 weeks), after wound healing, and obtaining the final pathological report with full immunohistochemistry and proper risk group assignment.

Doubly Accelerated Partial Breast Irradiation after Breast-Conserving Surgery

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: 50 years, postmenopausal
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage 0-II breast cancer
• Invasive ductal carcinoma (NOS, NST, other subtypes), invasive lobular carcinoma, ductal carcinoma in situ (DCIS)
• Invasive carcinoma/DCIS, which is unifocal and unicentric
• pT1-2, maximal tumor size \< 3 cm
• pN0 (no metastases to the nodes)
• LVI(-) - no lymphovascular invasion
• M0 (no distant metastases)
• Surgical margins free of cancer (no tumor on ink) in each direction; in the case of DCIS, the minimum margin of 2 mm in each direction
• Lack of indications to chemotherapy/immunotherapy pre- or postsurgically (e.g., triple-negative, HER2-positive breast cancer)
• Treatment start not later than 12 weeks after surgery (optimally 4-8 weeks, after wound healing)
• Informed handwritten signed patient's consent

You may not qualify if:

• stage III-IV breast cancer
• pT2-4, maximal tumor size ≥ 3 cm
• surgical margins cannot be properly microscopically assessed
• EIC(+) - presence of extensive intraductal component
• Paget's disease or microscopically assessed skin involvement
• pN1-3M1 (presence of nodal or distant metastases)
• pre- or postsurgical indications for chemotherapy/immunotherapy
• other cancer (less than five years at time of recruitment) except skin cancer or cured FIGO 0-I cervical cancer
• time of pregnancy or lactation
• collagen disorders (congenital or acquired)
• psychiatric disorder disabling patient's compliance
• breast appearance or postsurgical status disabling safe interstitial multicatheter implantation
• lack of informed handwritten signed patient's consent

Sponsors & Collaborators

• The Greater Poland Cancer Centre: lead

Study Sites (1)

Greater Poland Cancer Centre

Poznan, Greater Poland Voivodeship, 61-866, Poland

Location

Related Publications (56)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Adam Chicheł, PhD, MD

  Greater Poland Cancer Centre

  PRINCIPAL INVESTIGATOR

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: November 8, 2021
• First Posted: December 2, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

PL (1)