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Radiation

Partial Breast Irradiation for Early Stage Breast Cancer

Phase 2 & 3

Waitlist Available

Led By Benjamin D Smith

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS

Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial looks at how well a shorter, higher-dose radiation therapy works to treat early stage breast cancer. The cancer is only in the breast, and this treatment may have fewer side effects.

Who is the study for?

This trial is for patients with early stage breast cancer who've had breast conserving surgery, have estrogen receptor positive tumors, and no evidence of disease from prior non-breast cancers. It's not for those with nodal positivity beyond pN0(i+), history of radiation in the area, or previous invasive/in situ breast cancer.Check my eligibility

What is being tested?

The study tests hypofractionated partial breast irradiation to see if delivering higher doses over a shorter period is effective and results in fewer side effects than standard treatment. Only the part of the breast where cancer started is treated.See study design

What are the potential side effects?

Potential side effects may include skin changes, fatigue, pain or discomfort at the treatment site. Since it's localized therapy, systemic side effects are less common compared to full-breast radiation.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer has not spread to my lymph nodes.

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My final surgery showed no cancer cells at the edges of the removed tissue.

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My invasive cancer is estrogen receptor positive.

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I had cancer other than breast cancer, finished treatment over a month ago, and currently show no signs of it.

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My breast cancer is in a specific area that can be targeted with radiation.

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My breast tumor is 3 cm or smaller.

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I have been diagnosed with invasive breast cancer or ductal carcinoma in situ.

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I had surgery to remove part of my breast.

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

Risk of grade 2 or higher toxicity

Secondary outcome measures

Disease free survival (DFS)

Feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network

Incidence of adverse events

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (hypofractionated partial breast irradiation)Experimental Treatment3 Interventions

Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.

Group II: Arm II (hypofractionated partial breast irradiation)Active Control2 Interventions

Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,786,389 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,923,593 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Benjamin D SmithPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

301 Total Patients Enrolled

Media Library

Partial Breast Irradiation (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03077841 — Phase 2 & 3

$Breast Cancer Research Study Groups: Arm I (hypofractionated partial breast irradiation), Arm II (hypofractionated partial breast irradiation)$

Breast Cancer Clinical Trial 2023: Partial Breast Irradiation Highlights & Side Effects. Trial Name: NCT03077841 — Phase 2 & 3

Partial Breast Irradiation (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03077841 — Phase 2 & 3

Frequently Asked Questions

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

Are there active clinical trial sites for this research in North America?

"To minimize the burden on participants, the 14 sites for this study are based in cities close to where potential participants live. For example, there are sites in Houston, Atlanta and San Antonio."

Answered by AI

Are people with the qualifying medical conditions able to join this study currently?

"The study, which was initially posted on 2017-03-06, is still recruiting participants according to the most recent update on 2021-10-12 hosted on clinicaltrials.gov."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer

2017. "Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03077841.

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