~14 spots leftby Jul 2027

Hypofractionated Radiation for Breast Cancer

Recruiting in Palo Alto (17 mi)
+2 other locations
JD
Overseen byJoshua T. Dilworth
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: William Beaumont Hospitals
Disqualifiers: T4 disease, Other malignancy, Radiation history, others
No Placebo Group
Approved in 3 Jurisdictions

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hypofractionated Radiation for Breast Cancer?

Research shows that hypofractionated radiation, which uses fewer but larger doses of radiation, has similar outcomes to traditional radiation for early-stage breast cancer. Studies have found it to be effective with acceptable short-term side effects, and ongoing trials are exploring its broader use.12345

Is hypofractionated radiation therapy safe for humans?

Research shows that hypofractionated radiation therapy, used for breast cancer, is generally safe with long-term safety established, though some studies note potential for increased short-term side effects compared to traditional methods.678910

How is hypofractionated radiation treatment different from other breast cancer treatments?

Hypofractionated radiation treatment for breast cancer uses fewer, larger doses of radiation over a shorter period compared to traditional radiation therapy, making it more convenient and potentially less costly while providing similar outcomes.2341112

Research Team

JD

Joshua T. Dilworth

Principal Investigator

William Beaumont Hospitals

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

Life expectancy of >5 years
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.
See 11 more

Exclusion Criteria

My cancer has spread to nearby lymph nodes but not to distant parts of my body.
Pregnancy, active breast feeding, or refusal or inability to use highly effective means of contraception in participants of child-bearing potential
My scans show visible signs of cancer.
See 6 more

Treatment Details

Interventions

  • Hypofractionated Radiation (Radiation)
Trial OverviewThe 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.
Participant Groups
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 Canada for the following indications:

🇨🇦
Approved in Canada as Hypofractionated Radiotherapy for:
  • Endometrial cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials
153
Recruited
113,000+
Dr. Benjamin Schwartz profile image

Dr. Benjamin Schwartz

William Beaumont Hospitals

Chief Medical Officer since 2021

MD from George Washington University School of Medicine and Health Sciences, Master in Healthcare Management from Harvard University

Tina Freese Decker profile image

Tina Freese Decker

William Beaumont Hospitals

Chief Executive Officer since 2022

MBA from Stanford University

Findings from Research

Hypofractionated whole breast irradiation (WBI) has been shown to produce outcomes comparable to conventional radiation in early-stage breast cancer patients, suggesting it is a safe and effective treatment option.
Current trials, including a phase III study by the Radiation Therapy Oncology Group, are investigating the feasibility and effectiveness of adding a concurrent tumor bed boost to hypofractionated WBI, which may enhance treatment outcomes and broaden its use.
Accelerated fractionation with a concurrent boost for early stage breast cancer.Freedman, GM., White, JR., Arthur, DW., et al.[2022]
Recent advancements in radiation therapy for non-metastatic breast cancer, particularly hypofractionation and partial breast irradiation, have led to optimized treatment approaches that consider both patient and tumor characteristics.
Despite strong level-1 evidence supporting hypofractionation, its adoption in routine practice has been slow, prompting the AIRO Breast Cancer Group to issue position statements aimed at standardizing postoperative radiation therapy practices based on current evidence.
The Italian Association for Radiotherapy and Clinical Oncology (AIRO) position statements for postoperative breast cancer radiation therapy volume, dose, and fractionation.Meattini, I., Palumbo, I., Becherini, C., et al.[2023]
In a study of 2309 breast cancer patients, those receiving hypofractionated radiotherapy experienced significantly less acute skin reactions and pain compared to those receiving conventional fractionation, indicating a safer treatment option.
Hypofractionation also resulted in lower levels of patient-reported symptoms like burning, swelling, and fatigue during treatment, suggesting it may enhance patient comfort without compromising long-term outcomes.
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.Jagsi, R., Griffith, KA., Boike, TP., et al.[2022]

References

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. [2022]
Accelerated fractionation with a concurrent boost for early stage breast cancer. [2022]
Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. [2020]
Hypofractionated radiation therapy in the treatment of early-stage breast cancer. [2021]
The Italian Association for Radiotherapy and Clinical Oncology (AIRO) position statements for postoperative breast cancer radiation therapy volume, dose, and fractionation. [2023]
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]
Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. [2022]
Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. [2023]
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]
What are the minimal standards of radiotherapy planning and dosimetry for "hypofractionated" radiotherapy in breast cancer? [2018]
Hypofractionated radiotherapy in postmastectomy locally advanced breast cancer: an interim report on acute toxicities and dosimetry. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical experience using hypofractionated radiation schedules in breast cancer. [2022]