Active — Not RecruitingPhase 2

Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

United States350 participantsStarted 2015-10-14

Plain-language summary

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.

Who can participate

Age range50 Years – 90 Years

SexFEMALE

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Inclusion criteria

✓. 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.
✓. Stage 1 (pT1) breast cancer, excised with negative margins.
✓. clinically N0 or No Regional Lymph node (pN0) or sentinel node negative

Exclusion criteria

✕. Previous radiation therapy to the ipsilateral breast.
✕. Presence of a proportion of Ductal Carcinoma in-situ (DCIS) in the core biopsy specimen which is compatible with extensive intraductal component (EIC).

What they're measuring

Number of participants with grade 2 or 3 fibrosis between the two treatment groups will be compared.

Timeframe: 60 months

Trial details

NCT IDNCT02755896

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Malignant Neoplasm of Breast Stage I trials