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Radiation Therapy for Early Stage Breast Cancer
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.
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.
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.
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
449 Previous Clinical Trials
66,382 Total Patients Enrolled
14 Trials studying Breast Cancer
800 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,751 Total Patients Enrolled
941 Trials studying Breast Cancer
1,443,037 Patients Enrolled for Breast Cancer
Rutgers Cancer Institute of New JerseyOTHER
70 Previous Clinical Trials
18,557 Total Patients Enrolled
7 Trials studying Breast Cancer
1,723 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on hormonal therapy like tamoxifen or anastrozole.I am not currently on any chemotherapy, immunotherapy, or experimental drugs.I have not had cancer in my other breast or at the same time in the same breast.My cancer has not spread to distant parts of my body.I am either before or after menopause.I am fully active or can carry out light work.You need to have a test that shows you are not pregnant.I have had surgery to remove breast cancer, including checking the lymph nodes.My follow-up mammogram showed no signs of cancer-related calcium deposits.I haven't had any cancer except for nonmelanoma skin cancer in the last 5 years.I don't have multiple cancer areas in the same breast, or if I do, they've been tested and are not cancerous.I have not had radiotherapy for my current breast cancer.I do not have Paget's disease of the nipple.My cancer is in an early to mid-stage, not spread far.My surgery showed no cancer cells at the edges of the removed tissue.You have fewer than 10 lymph nodes that show signs of cancer.My cancer's hormone receptor status is not determined.I do not have any health conditions that would shorten my life to less than 2 years.I am eligible for chemotherapy based on certain conditions.My tumor is 5 cm or smaller.There are no signs of small calcium deposits in the breast before starting radiotherapy.I have a confirmed diagnosis of breast cancer.My breast is suitable for radiation treatment.My breast cancer is not lobular carcinoma in situ or a non-epithelial type.My cancer has not spread to my skin.My breast cancer can be removed with one surgery.My other lymph nodes are confirmed tumor-free by tests.I do not have any collagen vascular diseases.I have not had breast surgery that resulted in poor cosmetic outcomes before radiation.
Research Study Groups:
This trial has the following groups:- Group 1: B
- Group 2: A
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.
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