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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
137
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.
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
VCU Community Memorial Healthcenter
South Hill, Virginia, United States
To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment
The number of participants with incidence of lymphedema defined as ≥ 10% increase in arm circumference over baseline circumference compared to the contralateral arm measured every 6 months from the time of initiation of hypofractionated irradiation of breast and regional nodes through 3 years following the completion of radiation therapy in 2 patient cohorts: * Patients who have only had sentinel lymph node (SLN) biopsy for axillary staging * Patients who have had axillary lymph node (ALN) dissection for axillary staging
Time frame: 3 years
Determine 5-year rate of locoregional breast cancer recurrence
Number of participants with recurrence of breast cancer within the breast or in the lymph nodes in the ipsilateral axilla, supraclavicular/infraclavicular fossa, or ipsilateral internal mammary chain without evidence of distant disease within 5 years following the completion of radiation therapy
Time frame: 5 years
Determine 5-year rate of distant breast cancer recurrence
The number of participants recurrence of breast cancer in any area beyond the breast and regional limits within 5 years following the completion of radiation therapy
Time frame: 5 years
Evaluate arm function by the frequency of patient responses indicating moderate or large differences between ipsilateral and contralateral arm function on the Patient-Reported Outcomes Questionnaire
PROMIS (Patient-Reported Outcomes Measurement Information System) forms use validated, standardized, and often 5-point Likert scales (e.g., Never to Always, Not at all to Very much) to assess physical, mental, and social health across various domains like pain, fatigue, and function. Form Pro-L used for treatment group 1, and Form Pro-M/R for treatment groups 2 \& 3.
Time frame: Baseline, then 1 month, then every 6 months through 3 years following EBRT, then yearly in years 4 and 5.
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