High vs Standard Dose Radiation Therapy for Breast Cancer

Recruiting at570 trial locations

Overseen by Frank A. Vicini, MD, FACR

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

Research Team

Frank A. Vicini, MD, FACR

Principal Investigator

St. Joseph Mercy Oakland

Douglas W. Arthur, MD

Principal Investigator

Virginia Commonwealth University

Gary M. Freedman, MD

Principal Investigator

University of Pennsylvania

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.

Treatment Details

Interventions

• Higher per daily radiation therapy (Radiation Therapy)
• Standard per daily radiation therapy (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+

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

Dr. Gita Suneja

Radiation Therapy Oncology Group

Chief Medical Officer

MD from University of Utah School of Medicine

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School