High vs Standard Dose Radiation Therapy for Breast Cancer

Recruiting at 570 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Radiation Therapy Oncology Group

Must not be taking: Concurrent chemotherapy

Disqualifiers: Stage III/IV cancer, Bilateral cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks for hypofractionated arm, 5-7 weeks for standard arm

2354 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that concurrent chemotherapy for current breast cancer is not allowed, so you may need to discuss your specific medications with the trial team.

What data supports the effectiveness of high-dose radiation therapy for breast cancer?

Some studies suggest that high-dose therapy may improve relapse-free survival in breast cancer patients, with certain trials showing a trend favoring high-dose treatment. However, the results are mixed, and more research is needed to confirm these findings. ^{1 2 3 4 5}

Is high-dose radiation therapy for breast cancer safe?

High-dose radiation therapy for breast cancer generally has low mortality rates, but there is a risk of increased heart-related issues. Studies show a small increase in cardiovascular risk, but the overall survival benefit against breast cancer is higher. ^{2 5 6 7 8}

How does high-dose radiation therapy differ from standard-dose radiation therapy for breast cancer?

High-dose radiation therapy for breast cancer involves delivering a higher amount of radiation per session compared to standard-dose therapy, which may improve tumor control but also carries a risk of increased side effects. This approach is being studied to determine if it offers better outcomes for patients with high-risk or advanced breast cancer compared to conventional treatments. ^{2 9 10 11 12}

Research Team

Gary M. Freedman, MD

Principal Investigator

University of Pennsylvania

Douglas W. Arthur, MD

Principal Investigator

Virginia Commonwealth University

Frank A. Vicini, MD, FACR

Principal Investigator

St. Joseph Mercy Oakland

Julia R. White, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for women over 18 who've had early-stage breast cancer surgically removed within the last 50 days. They must not be pregnant, agree to use contraception during treatment, and have no history of certain cancers or severe illnesses. Breast implants are okay, but prior radiation therapy in the same area or plans for chemotherapy alongside this treatment disqualify them.

Inclusion Criteria

Patient must provide study specific informed consent prior to study entry

I had surgery to remove breast cancer and radiation on the whole breast without treating the lymph nodes.

For invasive breast cancer, the armpit area must be examined using one of the following methods:

Exclusion Criteria

I have been cancer-free for at least 5 years, except for non-melanoma skin cancer or cervical carcinoma in situ.

My treatment plan includes radiation therapy to the lymph nodes.

I plan to receive chemotherapy alongside other treatments for my breast cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either accelerated hypofractionated whole-breast irradiation with a concomitant boost or standard whole-breast irradiation with a sequential boost

3 weeks for hypofractionated arm, 5-7 weeks for standard arm

Evaluated weekly during radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

1 month, 6 months, 12 months, then annually

Treatment Details

Interventions

• Higher per daily radiation therapy
• Standard per daily radiation therapy

Trial Overview The study compares two types of radiation therapy after breast surgery: a higher dose given less frequently with a concurrent boost versus the standard daily dose with a sequential boost. It's randomized, meaning patients are put into groups by chance to see which method works best.

Participant Groups

Group I: Hypofractionated whole breast irradiation + concurrent boost Experimental Treatment 2 Interventions

Hypofractionated whole breast (H-WBI) irradiation with a concurrent boost

Group II: Whole breast irradiation + sequential boost Active Control 2 Interventions

Standard fractionation whole breast irradiation (WBI) with sequential boost.

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

A dose escalation trial of adjuvant cyclophosphamide and epirubicin in combination with 5-fluorouracil using G-CSF support for premenopausal women with breast cancer involving four or more positive nodes. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized trials of high-dose chemotherapy in breast cancer: fraud, the press and the data (or lessons learned in medical policy governing clinical research). [2018]

3. England pubmed.ncbi.nlm.nih.gov

Autologous stem cell transplantation in breast cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

High-dose therapy for breast cancer. [2007]

5. England pubmed.ncbi.nlm.nih.gov

A critique of the eleven randomised trials of high-dose chemotherapy for breast cancer. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Oncological Benefit versus Cardiovascular Risk in Breast Cancer Patients Treated with Modern Radiotherapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Recent Time Trends and Predictors of Heart Dose From Breast Radiation Therapy in a Large Quality Consortium of Radiation Oncology Practices. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

High dose chemotherapy with stem cell rescue for breast cancer: current status and future directions. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Studies with high-dose chemotherapy and subsequent autologous stem cell transplantation in breast carcinoma]. [2008]

10. United States pubmed.ncbi.nlm.nih.gov

High-dose chemotherapy for breast cancer: is another look warranted? [2019]

11. United States pubmed.ncbi.nlm.nih.gov

High-dose chemotherapy with autologous hematopoietic progenitor cell support for metastatic and high-risk primary breast cancer. [2007]

12. United States pubmed.ncbi.nlm.nih.gov

High-dose chemotherapy with autologous stem cell support for breast cancer: a review of the Dana-Farber Cancer Institute/Beth Israel Hospital experience. [2013]