High vs Standard Dose Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+570 other locations

Overseen ByFrank 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.

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:

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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.

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Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypofractionated whole breast irradiation + concurrent boostExperimental Treatment2 Interventions

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

Group II: Whole breast irradiation + sequential boostActive Control2 Interventions

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