Radiation Therapy for Early-Stage Breast Cancer

Recruiting in Palo Alto (17 mi)

+513 other locations

Overseen by Norman Wolmark, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NSABP Foundation Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Research Team

Norman Wolmark, MD

Principal Investigator

NSABP Foundation Inc

Eligibility Criteria

This trial is for early-stage breast cancer patients who've had surgery after chemotherapy. They must have T1-3, N1 cancer with confirmed axillary nodal involvement and no metastatic disease. Eligible participants should not be pregnant, have prior breast radiation, or severe systemic diseases. Performance status should be good (ECOG 0 or 1), and hormone receptor testing on the tumor is required.

Inclusion Criteria

My breast cancer was tested for HER2 before starting chemotherapy.

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

My breast cancer was tested for estrogen and progesterone receptors following ASCO/CAP guidelines.

Exclusion Criteria

You have mental health or addiction issues that could make it hard for you to participate in the study.

My breast cancer is advanced (T4) or inflammatory.

I have an active collagen vascular disease like dermatomyositis, lupus, or scleroderma.

Treatment Details

Interventions

• Chestwall XRT (Radiation Therapy)
• Regional Nodal XRT (Radiation Therapy)
• WBI (Radiation Therapy)

Trial Overview The study compares standard radiation therapy to comprehensive radiation therapy in treating early-stage breast cancer post-surgery. It aims to determine which method is more effective at killing remaining tumor cells without extensive side effects.

Participant Groups

Group I: Group 2B Mastectomy: Regional nodal XRT and chestwall XRT Experimental Treatment 2 Interventions

Mastectomy patients undergo regional nodal radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks.

Group II: Group 2A lumpectomy: Regional nodal XRT with WBI Experimental Treatment 2 Interventions

Lumpectomy patients undergo regional nodal radiation therapy with whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.

Group III: Group 1A Lumpectomy: no regional nodal XRT with WBI Active Control 1 Intervention

Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.

Group IV: Group 1B Mastectomy: No regional nodal or chestwall XRT Active Control 1 Intervention

Mastectomy patients do not undergo radiation therapy.

Who Is Running the Clinical Trial?

NSABP Foundation Inc

Lead Sponsor

Trials

89

Recruited

140,000+

Priya Rastogi

NSABP Foundation Inc

Chief Executive Officer since 2022

MD from University of Pittsburgh

Charles E. Geyer Jr.

NSABP Foundation Inc

Chief Medical Officer since 2022

MD from Texas Tech University

Radiation Therapy Oncology Group

Collaborator

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

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