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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to death from any cause, assessed up to 10 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer was tested for estrogen and progesterone receptors following ASCO/CAP guidelines.
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My breast cancer was stage T1-3, N1 at diagnosis.
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My cancer in the lymph nodes was confirmed by a needle test before starting treatment.
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I completed at least 8 weeks of specific chemotherapy before surgery.
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My surgery removed all visible cancer from the breast.
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My surgery showed no cancer in the lymph nodes removed from my armpit.
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My last breast cancer surgery or chemotherapy was less than 70 days ago.
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I have had either a total mastectomy or a lumpectomy.
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Side effects from my previous chemotherapy that could affect radiation treatment have gone away.
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My cancer has not spread to lymph nodes after initial treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization to death from any cause, assessed up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to death from any cause, assessed up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IBC-RFI
Secondary outcome measures
DFS-DCIS
DRFI
Effect of radiation therapy on cosmetic outcome in mastectomy and lumpectomy patients as assessed by quality of life questionnaire
+5 moreTrial 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
Find a Location
Who is running the clinical trial?
Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
63,291 Total Patients Enrolled
10 Trials studying Breast Cancer
10,411 Patients Enrolled for Breast Cancer
NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
135,352 Total Patients Enrolled
45 Trials studying Breast Cancer
100,530 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,517 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My cancer has spread to nearby lymph nodes.My cancer spread to underarm lymph nodes after initial treatment.I have or had cancer in my other breast but not LCIS.My breast cancer was tested for HER2 before starting chemotherapy.I have not received radiation for my current breast cancer before joining this study.I don't have any health conditions that would stop me from participating in the study.I haven't had any cancer other than breast cancer in the last 5 years.I have cancer cells at the edge of the tissue removed during my last surgery.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.My breast cancer was stage T1-3, N1 at diagnosis.My cancer in the lymph nodes was confirmed by a needle test before starting treatment.I completed at least 8 weeks of specific chemotherapy before surgery.I completed my chemotherapy within 14 weeks after surgery, before joining the trial.I have received treatment targeting HER2-positive cancer before surgery, unless it was not safe for me.My surgery removed all visible cancer from the breast.My surgery showed no cancer in the lymph nodes removed from my armpit.My lumpectomy margins are clear of cancer, or I had a mastectomy if they weren't.My last breast cancer surgery or chemotherapy was less than 70 days ago.I have had breast cancer or DCIS on the same side treated with radiation, except for LCIS.My cancer has spread to other parts of my body.My surgical wound has fully healed without any infection.I will stop any hormonal therapy, like birth control, before joining the study.I have had radiation therapy on my chest or breast before.I have had either a total mastectomy or a lumpectomy.Side effects from my previous chemotherapy that could affect radiation treatment have gone away.My tests showed cancer in the lymph nodes under my arm before starting treatment.My cancer has not spread to lymph nodes after initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2A lumpectomy: Regional nodal XRT with WBI
- Group 2: Group 2B Mastectomy: Regional nodal XRT and chestwall XRT
- Group 3: Group 1A Lumpectomy: no regional nodal XRT with WBI
- Group 4: Group 1B Mastectomy: No regional nodal or chestwall XRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many venues are currently offering this research study?
"The study is currently being conducted at 100 sites, including locations in Kansas City, Baton Rouge and Mount Pleasant. To minimize the burden of travel on participants, individuals should select a location nearest them when enrolling."
Answered by AI
Does this trial currently have any vacancies?
"Based on the publicly available data, this clinical trial is no longer in search of patients. It was initially posted on August 1st 2013 and last updated on May 6th 2022. Nonetheless, there are presently 2,291 other studies actively recruiting participants."
Answered by AI
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