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Radiation Therapy for Early Stage Breast Cancer

New Brunswick, NJ
Phase 2
Waitlist Available
Led By Bruce Haffty, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No other concurrent chemotherapy, immunotherapy, or experimental medications
No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at the side effects of radiation therapy and its effectiveness in treating early stage breast cancer in women.

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Who is the study for?
This trial is for women with early stage breast cancer who've had a lumpectomy or mastectomy, without prior treatment for the opposite breast. They should have no distant spread of cancer, be pre- or post-menopausal with good performance status, and not pregnant. Those on hormone therapy may join but can't have other cancers in the last 5 years (except nonmelanoma skin cancer) and must use contraception if fertile.Check my eligibility
What is being tested?
The study tests how well different methods of radiation therapy work after surgery to remove breast tumors. It aims to determine the effectiveness of whole breast irradiation with an external beam boost in killing any remaining tumor cells.See study design
What are the potential side effects?
Radiation therapy side effects can include skin changes like redness and irritation, fatigue, swelling in the treated area, pain or stiffness in the shoulder joint, and rarely more serious complications such as heart problems or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently on any chemotherapy, immunotherapy, or experimental drugs.
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I have not had cancer in my other breast or at the same time in the same breast.
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My cancer has not spread to distant parts of my body.
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I am either before or after menopause.
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I am fully active or can carry out light work.
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I have had surgery to remove breast cancer, including checking the lymph nodes.
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I don't have multiple cancer areas in the same breast, or if I do, they've been tested and are not cancerous.
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My follow-up mammogram showed no signs of cancer-related calcium deposits.
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I haven't had any cancer except for nonmelanoma skin cancer in the last 5 years.
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I have not had radiotherapy for my current breast cancer.
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I do not have Paget's disease of the nipple.
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My cancer is in an early to mid-stage, not spread far.
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My surgery showed no cancer cells at the edges of the removed tissue.
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I do not have any health conditions that would shorten my life to less than 2 years.
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My tumor is 5 cm or smaller.
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I have a confirmed diagnosis of breast cancer.
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My breast is suitable for radiation treatment.
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My breast cancer is not lobular carcinoma in situ or a non-epithelial type.
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My cancer has not spread to my skin.
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My breast cancer can be removed with one surgery.
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My other lymph nodes are confirmed tumor-free by tests.
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I do not have any collagen vascular diseases.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: BActive Control2 Interventions
Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost
Group II: AActive Control2 Interventions
3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)

Find a Location

Closest Location:RWJBarnabas Health - Robert Wood Johnson University Hospital· Somerset, NJ· 1263 miles

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
469 Previous Clinical Trials
81,312 Total Patients Enrolled
15 Trials studying Breast Cancer
11,211 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
14,038 Previous Clinical Trials
41,156,387 Total Patients Enrolled
951 Trials studying Breast Cancer
1,448,730 Patients Enrolled for Breast Cancer
Rutgers Cancer Institute of New JerseyOTHER
71 Previous Clinical Trials
21,957 Total Patients Enrolled
7 Trials studying Breast Cancer
1,723 Patients Enrolled for Breast Cancer
Bruce Haffty, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
3 Previous Clinical Trials
299 Total Patients Enrolled

Media Library

External Beam Boost Clinical Trial Eligibility Overview. Trial Name: NCT00909909 — Phase 2
Breast Cancer Research Study Groups: B, A
Breast Cancer Clinical Trial 2023: External Beam Boost Highlights & Side Effects. Trial Name: NCT00909909 — Phase 2
External Beam Boost 2023 Treatment Timeline for Medical Study. Trial Name: NCT00909909 — Phase 2
~25 spots leftby Jul 2027
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