Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer, Node-positive Breast Cancer, Breast Adenocarcinoma, Invasive Breast Carcinoma, Lobular Breast Carcinoma In Situ

In brief

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.

Key facts

Study ID

NCT02515110

Run by

Virginia Commonwealth University

People needed

137

Starts

2015-08-04

Expected to finish

2028-04-30

Last updated by the study team

2026-06-15

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Mastectomy alone with sentinel lymph node or axillary lymph node dissection
• Mastectomy plus reconstruction with sentinel lymph node or axillary lymph node dissection
• Margins of the resected specimen or re-excision specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist
• Notes: Additional operative procedures may be performed to obtain clear margins; focally positive margins are acceptable based on technical feasibility of additional surgery and/or the potential for benefit with further surgery based on the extent and location of the positive margin (eg, focally positive deep margin at the pectoralis fascia); also, patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection
• Estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) testing performed on the primary breast tumor; when applicable, testing must have been performed prior to neoadjuvant chemotherapy
• Interval between the last surgery for breast cancer (including re-excision of margins) or the completion of adjuvant chemotherapy and study enrollment must be =< 56 days (ie, a maximum of 8 weeks)
• Note: Radiotherapy must begin within 10 weeks following the last surgery for breast cancer or the last dose of adjuvant chemotherapy
• Recovery from surgery with the incision completely healed and no signs of infection
• If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of external beam radiation therapy (EBRT) should have resolved
• Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative pregnancy test within 14 days prior to study registration
• Note: Postmenopausal is defined as one or more of the following:

You may not qualify if…

• Known definitive clinical or radiologic evidence of metastatic disease
• T4 tumors including inflammatory breast cancer
• Clinical nodal staging of N2 or N3 disease
• Pathologic nodal staging of N2b, N2c, or N3 disease
• Microscopic positive margins after definitive surgery
• Note: Patients with microscopically focally positive margins following lumpectomy or mastectomy are not excluded if re-excision is not technically feasible and/or there is no benefit to further surgery based on the extent and location of the positive margin
• Any history, not including the index cancer, of ipsilateral or contralateral invasive breast cancer or ipsilateral or contralateral DCIS treated with radiation therapy (RT)
• Note: Patients with synchronous or previous ipsilateral LCIS are eligible
• Any radiation therapy (RT) for the currently diagnosed breast cancer prior to study enrollment
• History of ipsilateral or contralateral breast or thoracic RT for any condition
• History of ipsilateral or contralateral axillary surgery for any condition
• History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
• Synchronous contralateral breast cancer requiring RT
• Overall geometry (eg, breast size if intact breast) precludes the ability to achieve dosimetric requirements
• Note: Set-up devices for breast positioning are permitted
• Unresolved post-surgical complications (eg, significant infection) with healing difficulties
• Active collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
• Pregnancy or breastfeeding
• Diagnosis or treatment for a non-breast malignancy within 5 years of study registration, with the following exceptions: complete resection of basal cell carcinoma or squamous cell carcinoma of the skin and any in situ malignancy after curative therapy
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Where it is running

• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States
• VCU Community Memorial Healthcenter — South Hill, Virginia, United States

Full record on ClinicalTrials.gov

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