Radiation Therapy for Breast Cancer

Recruiting at7 trial locations

Overseen by Benjamin D. Smith, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and have fewer side effects. It is not yet known if hypofractionated RT is more effective than standard RT in treating breast cancer.

Research Team

Benjamin D. Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients who've had breast-conserving surgery for ductal carcinoma in situ or early invasive breast cancer, with no tumor cells at the surgical margin. It's not open to those pregnant, with bilateral or advanced-stage breast cancer, more than 4 affected lymph nodes, metastases, previous breast cancers or radiation therapy in relevant areas.

Inclusion Criteria

My breast cancer is in the early stages and has not spread widely.

My last surgery showed no cancer at the edges of the tissue removed.

I had surgery to remove part of my breast.

Exclusion Criteria

My cancer has spread to distant parts of my body.

I have been diagnosed with breast cancer before.

Pregnancy

Treatment Details

Interventions

• Conventionally Fractionated Whole Breast Irradiation (Radiation Therapy)
• External Beam Radiation Therapy (Radiation Therapy)
• Hypofractionated Radiation Therapy (Radiation Therapy)
• Hypofractionated Whole Breast Irradiation (Radiation Therapy)
• Whole Breast Irradiation (Radiation Therapy)

Trial Overview The study compares two types of radiation therapy: hypofractionated (higher doses over a shorter period) and standard treatment. The goal is to see if the shorter-duration treatment is as effective while potentially causing fewer side effects.

Participant Groups

Group I: Arm I (HF-WBI) Experimental Treatment 6 Interventions

Patients undergo HF-WBI comprising external beam RT 5 days a week for approximately 3 weeks.

Group II: Arm II (CF-WBI) Active Control 5 Interventions

Patients undergo CF-WBI comprising external beam RT 5 days a week for approximately 5 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

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