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 range40 Years

SexFEMALE

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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…

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 completion2026-04-30