Trial Summary
What is the purpose of this trial?This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. After enrollment, participants will be stratified into 2 Groups based on the extent of axillary surgery. Participants will complete activities and assessments at baseline, and after completion of treatment at 1-2 weeks, 3 months, 6 months, 1 year, 2 year, and 3 years following completion of treatment.
What safety data exists for hypofractionated radiation in breast cancer treatment?Several studies have evaluated the safety of hypofractionated radiation for breast cancer. Randomized trials have confirmed its long-term safety and efficacy, though there is less data on acute toxic effects compared to conventional fractionation. Hypofractionation is becoming the standard of care, with studies assessing its toxicities and outcomes. Ultra-hypofractionation is also considered safe, with reports on its efficacy and tolerance. An interim report on accelerated hypofractionation shows manageable adverse effects after a minimum of 3 years. Concerns about increased toxicity exist, but proper planning and dosimetry can mitigate these risks.236812
What data supports the idea that Hypofractionated Radiation for Breast Cancer is an effective treatment?The available research shows that hypofractionated radiation, which uses fewer and larger doses over a shorter time, has outcomes comparable to traditional radiation for early-stage breast cancer. Studies, including randomized trials, have demonstrated that this treatment is effective in controlling cancer without significantly increasing side effects. Ongoing trials are further exploring its effectiveness, which could lead to wider acceptance of this treatment for early-stage breast cancer.457910
Is Hypofractionated Radiation a promising treatment for breast cancer?Yes, Hypofractionated Radiation is a promising treatment for breast cancer. It allows for fewer and larger doses of radiation over a shorter time, which can be more convenient and less costly. Studies show it works as well as traditional radiation in preventing cancer from coming back and maintaining the breast's appearance. Ongoing research is likely to make this treatment more widely accepted for early-stage breast cancer.145711
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.
Eligibility Criteria
This trial is for women over 18 with breast cancer who have a life expectancy of more than 5 years and are in good physical condition. They must not be pregnant, breastfeeding, or refuse contraception if of child-bearing potential. Participants should have certain stages of tumor and node involvement but no history of radiation to the neck, breast, or thorax.Inclusion Criteria
I am fully active and can carry on all my pre-disease activities without restriction.
My cancer has not spread to more than a few nearby lymph nodes.
My cancer has not spread to distant parts of my body.
My breast cancer is at an early to mid-stage, according to pathology reports.
I am female.
I am 18 years old or older.
My breast cancer diagnosis is confirmed by tissue analysis.
My breast cancer is in an early to locally advanced stage.
I had breast surgery with all cancer removed.
My breast cancer has spread to certain lymph nodes but not beyond.
Exclusion Criteria
My cancer has spread to nearby lymph nodes but not to distant parts of my body.
My scans show visible signs of cancer.
I have had breast cancer or DCIS in the same breast before.
I have a history of diseases like lupus with high CK levels.
My breast cancer is at an advanced stage or inflammatory.
Treatment Details
The study tests hypofractionated regional nodal irradiation's effectiveness and safety in breast cancer patients post-surgery. It involves two groups based on axillary surgery extent, with follow-ups from 1-2 weeks up to 3 years after treatment completion.
2Treatment groups
Experimental Treatment
Group I: Group 2: axillary lymph node dissectionExperimental Treatment1 Intervention
Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure). Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
Group II: Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodesExperimental Treatment1 Intervention
Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes. Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.
Hypofractionated Radiation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Hypofractionated Radiotherapy for:
- Endometrial cancer
🇪🇺 Approved in European Union as Hypofractionated Radiotherapy for:
- Endometrial cancer
- Cervical cancer
🇨🇦 Approved in Canada as Hypofractionated Radiotherapy for:
- Endometrial cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Corewell Health William Beaumont University HospitalDearborn, MI
Corewell Health William Beaumont University HospitalRoyal Oak, MI
Corewell Health William Beaumont University HospitalTroy, MI
Loading ...
Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
References
Clinical experience using hypofractionated radiation schedules in breast cancer. [2022]Hypofractionation is attractive for whole- or partial-breast irradiation because it permits treatment to be given with fewer fractions in a shorter period of time and at less cost. A number of cohort studies suggest that hypofractionation may be given to the whole breast safely and with good local control. Recent randomized trials have confirmed that hypofractioned whole-breast irradiation is equivalent to more conventional whole-breast irradiation with respect to local recurrence and cosmetic outcome. Recently, there has been a renewed interest in hypofractionation for the delivery of partial-breast irradiation using a number of techniques including high-dose rate brachytherapy, 3-dimensional conformal radiation using external-beam techniques, and intraoperative therapy. Early cohort studies report good local control and acceptable morbidity. Randomized trials are now underway to compare this approach to conventional whole-breast irradiation.
Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minimum follow up of 3 years. [2021]Accelerated hypofractionation is an attractive approach for adjuvant whole breast radiotherapy. In this study we evaluated the adverse effects at least 3 years post an accelerated hypofractionated whole breast radiotherapy schedule.
What are the minimal standards of radiotherapy planning and dosimetry for "hypofractionated" radiotherapy in breast cancer? [2018]Hypofractionated radiotherapy regimens have become increasingly popular in breast cancer, particularly in the UK and Canada. However, there are some potential problems inherent to providing such regimens, such as the concern of increased toxicity. In this article we discuss the planning and dosimetry and requirements for hypofractionated radiotherapy in breast cancer and make recommendations both for the planning process and for treatment monitoring.
Hypofractionated radiation therapy in the treatment of early-stage breast cancer. [2021]Hypofractionated radiation refers to the use of fewer, larger-dose radiation treatments that are usually given over a shorter time period compared to conventional radiation fraction sizes. Randomized trials of hypofractionated whole breast irradiation (WBI) have demonstrated comparable outcomes as conventional fractionation. For a higher-risk population for local recurrence, a phase 3 trial by the Radiation Therapy Oncology Group (RTOG) is currently studying hypofractionated WBI with a concurrent tumor bed boost over 3 weeks. Accelerated partial breast irradiation limits radiation to the region of the tumor bed for 1-3 weeks and is the subject of an ongoing randomized trial by the National Surgical Breast and Bowel Project and RTOG. Questions remain for hypofractionation about optimal patient selection, radiation techniques, and the risk of late toxicity. But results from current trials could make hypofractionation more widely accepted for patients with early-stage breast cancer.
Accelerated fractionation with a concurrent boost for early stage breast cancer. [2022]Hypofractionated radiation refers to treatment with greater than 2 Gy per fraction, usually in fewer number and an overall shorter treatment period, compared to conventional radiation fractionation. Randomized prospective trials of hypofractionated whole breast irradiation (WBI) have demonstrated comparable outcomes as conventional fractionation in early stage postlumpectomy radiation in selected groups of patients. These data have changed the traditional radiobiology estimation of the alpha/beta ratio that predicted fractionation sensitivity for breast cancer, suggesting that further increase in dose per fraction is possible for early stage breast cancer without significantly increasing late effects. Many questions remain regarding hypofractionated WBI and span from optimal patient selection to radiation technique including dose planning optimization and the incorporation of a tumor bed boost. A concurrent radiation boost has been studied in a number of single institution studies and has shown to be feasible with acceptable acute and short-term late toxicity. A phase III trial by the Radiation Therapy Oncology Group (RTOG 1005) in North America and other trials in Europe are currently studying in-breast cancer control from hypofractionated WBI with a concurrent tumor bed boost. Results from these current trials could improve the acceptance and broaden the applicability of hypofractionation treatment courses for the treatment of patients with early stage breast cancer.
Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort. [2022]Randomized trials have established the long-term safety and efficacy of hypofractionated whole-breast radiotherapy, but little is known about the acute toxic effects experienced by patients treated with hypofractionation as compared with conventional fractionation, particularly in real-world settings and from the patient's own perspective.
Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. [2020]Hypofractionated radiotherapy for breast cancer is becoming increasingly important. The scientific background of this development as well as the introduction of the simultaneous integrated boost to the primary tumor region in this context are discussed here.
Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. [2022]Hypofractionation is now becoming the standard of care in breast irradiation. The aim of this study was to assess the toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy (HFRT).
Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. [2022]Application of hypofractionated radiotherapy (HFRT) is growing in patients with breast cancer (BC). This study aimed to explore a real-world practice of HFRT in early and locally advanced BC.
The Italian Association for Radiotherapy and Clinical Oncology (AIRO) position statements for postoperative breast cancer radiation therapy volume, dose, and fractionation. [2023]Recent advances in non-metastatic breast cancer radiation therapy significantly reshaped our views on modern dose and fractionation schedules. Especially the advent of hypofractionation and partial breast irradiation defined a new concept of treatment optimization, that should strongly include both patient and tumour characteristics in the physician's decision-making process. Unfortunately, hypofractionation for breast cancer radiation therapy needed long time to enter the routine practice during the last decades despite the level-1 evidence published over time. Hereby we present the Italian Association for Radiotherapy and Clinical Oncology (AIRO) Breast Cancer Group position statements for postoperative breast cancer radiation therapy volume, dose, and fractionation to harmonically boost routine clinical practice implementation following evidence-based data.
Hypofractionated radiotherapy in postmastectomy locally advanced breast cancer: an interim report on acute toxicities and dosimetry. [2023]There is a growing interest in the use of hypofractionation in the setting of post-mastectomy radiation therapy (PMRT). Here, we present an interim report on the acute toxicities and the dosimetry of a 15-day hypofractionated regimen.
Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. [2023]Ultra-hypofractionation breast radiotherapy is a safe alternative to moderate hypofractionation. This study reports the results of two ultrahypofractionated regimens used in clinical practice in a high-volume radiotherapy center in terms of efficacy and of tolerance.