Hypofractionated Regional Nodal Irradiation Phase 2 Clinical Trial for Women With Breast Cancer - HeNRIetta
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.
• 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 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:
⁃ Age \>= 60 years
⁃ Age \< 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range
⁃ Bilateral oophorectomy
• Women of child-bearing potential (WCBP) must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment
• Ability to understand and willingness to sign the consent form written in English pregnancy test within 14 days prior to study registration
• \* Note: Postmenopausal is defined as one or more of the following:
⁃ Age \>= 60 years
⁃ Age \< 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range
⁃ Bilateral oophorectomy
• Women of child-bearing potential (WCBP) must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment
• Ability to understand and willingness to sign the consent form written in English