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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 5 years

Awards & highlights

Study 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.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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Loco-regional control as assessed by physical examination, mammography, and other relevant imaging

Secondary outcome measures

Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale

Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0

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)

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,032 Total Patients Enrolled

15 Trials studying Breast Cancer

1,710 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,289 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,160 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

B Clinical Trial Eligibility Overview. Trial Name: NCT00909909 — Phase 2

Breast Cancer Research Study Groups: B, A

Breast Cancer Clinical Trial 2023: B Highlights & Side Effects. Trial Name: NCT00909909 — Phase 2

B 2023 Treatment Timeline for Medical Study. Trial Name: NCT00909909 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research allow for participants aged under 60 years?

"To be considered for this specific study, the age of potential participants must fall within 18 to 120 years old. Additionally, there are 74 trials aimed at those younger than 18 and 2501 studies intended for individuals over 65."

Answered by AI

Has B gained the approval of the Food and Drug Administration?

"The safety of B is judged to be a 2, as it has only been tested and demonstrated safe in Phase 2 trials with no efficacy data yet."

Answered by AI

Who satisfies the prerequisites to qualify for this research trial?

"In order to qualify for this trial, applicants must have a diagnosis of breast cancer and be between 18-120 years old. Currently 200 individuals are being sought out as participants."

Answered by AI

Does this medical trial remain open to new participants?

"Information hosted on clinicaltrials.gov indicates that this medical trial is no longer recruiting participants, as the last update was made on July 27th 2022. Nevertheless, there are 2,596 other trials actively looking for patients right now."

Answered by AI

Recent research and studies

International Journal of Radiation Oncology*Biology*PhysicsJournal

Short-course Hypofractionated Radiation Therapy with Boost in Women with Stages 0 to Iiia Breast Cancer: A Phase 2 Trial

Ahlawat, Stuti, Bruce G. Haffty, Sharad Goyal, Thomas Kearney, Laurie Kirstein, Chunxia Chen, Dirk F. Moore, and Atif J. Khan. 2016. “Short-course Hypofractionated Radiation Therapy with Boost in Women with Stages 0 to Iiia Breast Cancer: A Phase 2 Trial”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2015.09.011.

clinicaltrials.govStudy

Radiation Therapy in Treating Women With Early Stage Breast Cancer

Bruce G Haffty 2009. "Radiation Therapy in Treating Women With Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00909909.

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