Malignant Neoplasm of Breast Stage I Clinical Trial
Official title:
Prone Partial Breast Irradiation (PBI): Prospective Randomized Controlled Non-inferiority Trial to Compare Radiation Fibrosis With Five Versus Three Fractions
Verified date | February 2024 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.
Status | Active, not recruiting |
Enrollment | 350 |
Est. completion date | July 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Post-menopausal women with status post segmental mastectomy defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with Follicle Stimulating Hormone (FSH) confirmation of post-menopausal status. 2. Stage 1 (pT1) breast cancer, excised with negative margins. 3. clinically N0 or No Regional Lymph node (pN0) or sentinel node negative Exclusion Criteria: 1. Previous radiation therapy to the ipsilateral breast. 2. Presence of a proportion of Ductal Carcinoma in-situ (DCIS) in the core biopsy specimen which is compatible with extensive intraductal component (EIC). |
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
United States | Brooklyn Methodist Hospital - NewYork Presbyterian | New York | New York |
United States | New York Presbyterian Hospital - Queens | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with grade 2 or 3 fibrosis between the two treatment groups will be compared. | The primary analysis will be the difference in proportions of patients with grade 2 or 3 fibrosis between the two treatment groups compared using a non-inferiority z- test. The proportions of patients by grade of fibrosis will be compared in the two treatment arms using contingency table methods and chi square tests. | 60 months | |
Secondary | Recurrence rates will be documented | Rates of recurrence at 1, 2, and 3 years post-randomization will be estimated with 95% confidence limits within treatment groups along with plots of Kaplan-Meier time to recurrence curves | 60 months |