Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

Trial ID or NCT#

NCT03422003

Status

not recruiting iconNOT RECRUITING

Purpose

This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.

Official Title

Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor2. Has been treated with mastectomy3. Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy4. Is a candidate for unilateral post-mastectomy radiation therapy as per National Comprehensive Cancer Network (NCCN) guidelines (post-mastectomy radiation therapy is indicated for most patients with positive lymph nodes at time of surgery and infrequently for selected node-negative patients)5. Use of bolus is permitted, but not required6. Age ≥18
Exclusion Criteria:
  1. 1. T4 cancer2. Recurrent breast cancer or history of prior breast radiation therapy3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or mental health illness that the consenting investigator feels would affect patient's ability to participate in this study4. Pregnant or nursing5. History of a different malignancy except for the following circumstances:
    1. * Disease-free for at least five years and deemed by the investigator to be at low risk for recurrence of that malignancy (\<5 %). * Cervical cancer in situ and basal cell or squamous cell carcinoma of the skin6. Breast cancer requiring bilateral breast/chest wall radiation therapy.
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Investigator(s)

Kathleen Horst, MD
Kathleen Horst, MD
Radiation oncologist
Professor of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

Elanor Catherine Irvine Brown
650-724-4606

View on ClinicalTrials.gov