Active — Not RecruitingNot Applicable

Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer

United States137 participantsStarted 2015-08-04

Plain-language summary

Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3) plans for locoregional EBRT following mastectomy with reconstruction. Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with reconstruction, cosmetic outcome.

Who can participate

Age range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Karnofsky performance status of 70-100% * Histologic documentation of invasive adenocarcinoma of the breast * One of the breast disease stages listed below: * Note: In the definitions below, definitive surgery is defined as the final surgery performed to obtain clear surgical margins * Neoadjuvant chemotherapy was not administered \*\* If neoadjuvant chemotherapy was NOT administered, pathologic staging must be T1-3, N1-2a following definitive surgery * Neoadjuvant chemotherapy was administered * If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N0, pathologic staging must be T1-3, N1-2a following definitive surgery * If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N1, pathologic staging must be T0-3, N0-2a following definitive surgery * If prior to initiation of neoadjuvant chemotherapy there was cytologic or pathologic confirmation of axillary nodal involvement (per any of the criteria listed below), pathologic staging must be T0-3, N0-2a following definitive surgery * Positive fine-needle aspiration (FNA) (ie, demonstrating malignant cells) * Positive core needle biopsy (ie, demonstrating invasive adenocarcinoma) * Positive sentinel lymph node biopsy (ie, demonstrating invasive adenocarcinoma) * Complete resection of known breast disease by one of the following surgeries: * Lumpectomy with sentinel lymph node or axillary lymph node dissection * Maste…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically studying lymphedema risk over 3 years after hypofractionated radiation to the lymph node regions — given my specific diagnosis and the nodes involved, how does my personal lymphedema risk compare to what this study is trying to measure?
2Hypofractionated radiation delivers larger doses over fewer sessions compared to standard radiation — can you walk me through how that difference might affect both my day-to-day treatment schedule and what is currently known about its safety for treating the lymph node areas, not just the breast?
3Since this trial is listed as active but no longer recruiting, would my care team have access to any early findings or emerging data from this study that could inform the radiation approach you'd recommend for me?
4This trial focuses on node-positive breast cancer, which describes my situation — is hypofractionated regional nodal irradiation something you'd consider as part of my treatment plan, or would standard fractionation still be the preferred path given where the evidence currently stands?
5Because lymphedema can have a real impact on daily life and arm function, what monitoring or early-intervention plan would be in place for me regardless of which radiation approach we choose?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment

Timeframe: 3 years

Trial details

NCT IDNCT02515110

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-22

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