Hypofractionated Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+863 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

Eligibility Criteria

This trial is for women with stage IIa-IIIa breast cancer who've had a mastectomy. They must not be pregnant, have no history of certain other cancers or severe diseases, and agree to birth control if of childbearing potential. Participants should not have received prior chest radiation and must plan to start treatment within specific timeframes.

Inclusion Criteria

I haven't had radiation therapy to my chest, neck, or armpit area; but I may have had radioactive iodine treatment.

My mastectomy showed no cancer cells at the edges of the removed tissue.

I do not have any active collagen vascular diseases like lupus.

My breast cancer is confirmed and not metaplastic.

I have never had breast cancer or DCIS in the same breast before, but benign conditions are okay.

My tissue expander is filled with fluid, not air, if I'm undergoing radiation therapy.

I am fully active or restricted in physically strenuous activity but can do light work.

My radiation treatment does not include a boost to the chest wall or scar.

My breast cancer is at an early stage and has not spread to distant parts of my body.

I do not have any health conditions that could shorten my life to under 5 years.

Participant Groups

The study tests hypofractionated radiation therapy, which uses higher doses over a shorter period than traditional radiation, after mastectomy to prevent cancer recurrence. It includes lab biomarker analysis and quality-of-life assessments.

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (hypofractionated radiation therapy)Experimental Treatment4 Interventions

Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.

Group II: Group I (radiation therapy)Active Control4 Interventions

Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Hypofractionated Radiotherapy for: