← Back to Search

Radiation Therapy

Radiation Therapy for Early-Stage Breast Cancer

N/A

Waitlist Available

Led By Norman Wolmark, MD

Research Sponsored by NSABP Foundation Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org)

Must not have

Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma

N2 or N3 disease detected clinically or by imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tissue samples collected within 90 days after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two types of radiation therapy to treat early-stage breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Radiation therapy may cause skin irritation, fatigue, swelling in treated areas, mild to moderate pain, and potential long-term changes in breast size and shape. Rarely it can lead to heart problems or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

My breast cancer was stage T1-3, N1 at diagnosis.

Select...

My cancer in the lymph nodes was confirmed by a needle test before starting treatment.

Select...

I completed at least 8 weeks of specific chemotherapy before surgery.

Select...

My surgery removed all visible cancer from the breast.

Select...

My surgery showed no cancer in the lymph nodes removed from my armpit.

Select...

My last breast cancer surgery or chemotherapy was less than 70 days ago.

Select...

I have had either a total mastectomy or a lumpectomy.

Select...

Side effects from my previous chemotherapy that could affect radiation treatment have gone away.

Select...

My cancer has not spread to lymph nodes after initial treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My cancer has spread to nearby lymph nodes.

Select...

My breast cancer is advanced (T4) or inflammatory.

Select...

My cancer spread to underarm lymph nodes after initial treatment.

Select...

I have not received radiation for my current breast cancer before joining this study.

Select...

I haven't had any cancer other than breast cancer in the last 5 years.

Select...

I have cancer cells at the edge of the tissue removed during my last surgery.

Select...

My cancer has spread to other parts of my body.

Select...

I have had radiation therapy on my chest or breast before.

Select...

My tests showed cancer in the lymph nodes under my arm before starting treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tissue samples collected within 90 days after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tissue samples collected within 90 days after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and tissue samples collected within 90 days after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Molecular predictors of recurrence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group 2B Mastectomy: Regional nodal XRT and chestwall XRTExperimental Treatment2 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 WBIExperimental Treatment2 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 WBIActive Control1 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 XRTActive Control1 Intervention

Mastectomy patients do not undergo radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

WBI

2017

N/A

~230

0 / 21Eligibility criteria met