High Five (HiFi) Accelerated Partial Breast Irradiation Study (HiFi)

January 2, 2024 updated by: The Greater Poland Cancer Centre

Doubly Accelerated Partial Breast Irradiation After Breast-Conserving Surgery for Early Breast Cancer - High Five (HiFi) APBI Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Early low-risk breast cancer treatment with high-dose-rate brachytherapy (HDR-BT) (according to GEC-ESTRO, ASTRO, ABS recommendations) as a sole adjuvant treatment to the tumor bed after breast-conserving surgery (BCS) is acknowledged by prominent oncological societies in Poland and the world (PTB - Polish Brachytherapy Society, PTRO - Polish Society for Radiation Oncology, PTO - Polish Society of Oncology, ESTRO, ABS, ASTRO, ASCO). Treatment with multicatheter interstitial HDR-BT in the form of accelerated partial breast irradiation (APBI) was successfully verified in multi-institutional randomized clinical trials (Hungarian trial, GEC-ESTRO trial). It defined the currently widely used oncologically effective and clinically safe irradiation scheme of 8 x Gy in 5 days or 7 x 4,3 Gy in 4 days. In the USA, the irradiation scheme of 10 x 3,4 Gy is widely used in 5-10 days (e.g., NSABP-B39). Some European and American centers are investigating and publishing preliminary results of extremely shortened irradiation schemes of 4 x 6,25 Gy or 3 x 7,5 Gy in 2-3 treatment days, perioperatively (vAPBI trial - Valencia, TRIUMPH-T trial - Phoenix). In the Brachytherapy Department at Greater Poland Cancer Center (GPCC), the listed regimen of 7-8 x 4-4,3 Gy in 4-5 days has been used successfully since 2008. It results in very high local control rates and very low radiation-induced toxicity. APBI after BSC ensures, in properly selected low-risk patients, an equivalent local control rate and lower toxicity compared to whole breast irradiation with external beam radiation therapy (EBRT) The study hypothesis is that an additional moderately shortened irradiation scheme of 5 x 5,4 Gy in 3 consecutive days (two fractions daily with minimal 6 hours gap between fractions) does not increase early toxicity and 2-years late toxicity (primary endpoint). Also, it ensures the same or potentially higher 2-years local control probability compared to the standard regimen (control group).

What is essential, all the above-listed regimens are equivalent in terms of EQD2 calculations. The advantage of higher fraction doses that enable scheme shortening is relatively low radiobiological α/β ratio, estimated for breast cancer at around 4.

The study's primary goal is to prove the possibility of further gradual shortening of the total time of postoperative adjuvant treatment, thus, in the face of increasing breast cancer morbidity, increasing its accessibility. Indirectly, the shortened regimen may decrease the financial burden of the patient and the health system, reduce the patient's oncological treatment-related stress, absence from work, and separation from family. The project feasibility is likely since the only difference between standard and experimental procedures is in the dose and its number.

It's a prospective mono-institutional non-randomized open-label pilot study which results would be a base for further research on larger patients' groups in an anticipated multi-institutional randomized study.

The primary endpoint is to establish the role of adjuvant HDR brachytherapy in the allowable 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 patients with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.

Secondary endpoints: 1. Assessment of 2-years local control rate; 2. Review of 2-years cosmetic result; 3. Evaluation of the quality of life (QOL); 4. Evaluation of the overall survival (OS), disease-free survival (DFS), and distant metastases free survival (DFMS); 5. Analysis of the performed surgical approaches (tumorectomy, quadrantectomy, oncoplasty) preceding HDR-BT and their influence on the cosmetic results.

It is assumed to recruit a minimum of 60 participants in 2-3 years. The historical control group from the last three years counts over a hundred patients. The study is planned to be continued for up to 5 years to reach a substantially extended follow-up of 2 years.

Assumed causes of study termination: the occurrence of two or more cases of the treated area fat necrosis in which surgical intervention would be necessary (conservative treatment ineffective); too low recruitment (less than one-third of planned); occurrence of two or more similar and earlier not observed cases.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Greater Poland
      • Poznań, Greater Poland, Poland, 61-866
        • Greater Poland Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doubly Accelerated Partial Breast Irradiation after Breast-Conserving Surgery

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjuvant treatment - the early toxicity incidence
Time Frame: Up to 48 months
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
Time Frame: up to 48 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Greater Poland Cancer Centre

Investigators

  • Principal Investigator: Adam Chicheł, PhD, MD, Greater Poland Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiFi-APBI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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