Breast Cancer Clinical Trial
Official title:
Hypofractionated Regional Nodal Irradiation Phase 2 Clinical Trial for Women With Breast Cancer - HeNRIetta
Verified date | April 2024 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 137 |
Est. completion date | January 24, 2025 |
Est. primary completion date | January 24, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility | 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 - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | VCU Community Memorial Healthcenter | South Hill | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment | 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 SLN biopsy for axillary staging Patients who have had ALN dissection for axillary staging |
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