NCT02515110

Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer

Hypofractionated Regional Nodal Irradiation Phase 2 Clinical Trial for Women With Breast Cancer - HeNRIetta

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The HeNRIetta Trial is a phase 2 non-randomized clinical trial to evaluate the safety and effectiveness of hypofractionated RNI for women with resected node-positive breast cancer. The study hypothesis is that a 3-4 week hypofractionated course of post-lumpectomy or postmastectomy EBRT is as safe and effective as the biologically equivalent dose given in conventional fractionation over 5-7 weeks. Eligible patients are women ≥ 40 years old who have undergone definitive surgery for node-positive breast cancer. Surgery may have been lumpectomy, mastectomy without reconstruction, or mastectomy with reconstruction. Nodal staging may have been performed by only sentinel lymph node (SLN) or by axillary lymph node (ALN) dissection. Patients may have received neoadjuvant or adjuvant chemotherapy at the discretion of the treating medical oncologist. Breast and RNI will be administered to 42.56 Gy in 16 fractions. (RNI will exclude the axilla in patients who have had an ALN dissection.) A treatment boost of 4 to 6 fractions of 2.66 Gy/fraction to the lumpectomy cavity will be included for all patients who have had lumpectomy; a chestwall boost (4 to 6 fractions of 2.66 Gy/fraction) will be administered to patients who had mastectomy (with or without reconstruction) and close (\< 2 mm) surgical margins. Total number of EBRT fractions will be 20 to 22 with a boost; 16 without a boost. Bilateral measurements of arm circumference will be used to assess lymphedema by comparing the ipsilateral arm to the contralateral arm. Patients will also be assessed for and will complete questionnaires related to lymphedema, decreased arm function, breast and chestwall pain, other EBRT-related toxicities, cosmetic outcome, and local, regional, and distant breast cancer recurrence.

Conditions

• Breast Cancer
• Node-positive Breast Cancer
• Breast Adenocarcinoma
• Invasive Breast Carcinoma
• Lobular Breast Carcinoma In Situ

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Breast or chest wall irradiation with hypofractionated regional nodal irradiation (RNI) will be delivered according to a hypofractionated treatment schedule of 16 fractions followed by boost of 4 to 6 fractions for patients who had a lumpectomy; a boost of 4 to 6 fractions may also be required for patients who had a mastectomy (with or without reconstruction) if the surgical margin is \< 2 mm.

Timeline

• Start date: 2015-08-04
• Primary completion: 2026-04-30
• Completion: 2028-04-30
• First posted: 2015-08-04
• Last updated: 2026-03-13

Locations

2 sites across 1 country: United States