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

Protocol # :
Breast Cancer
Disease Sites
Principal Investigator
Punglia, Rinaa, S
Site Investigator
Ho, Alice
Katz, Matthew
Lingos, Tatiana, I.
Recht, Abram
Shiloh, Ron, Y.
Soto, Daniel, E.
Taghian, Alphonse, G.
Tillman, Gayle
Warren, Laura
Wong, Julia, S.
Site Research Nurses
Hincks, Gayle
Hixon, Nicole, R.
Homan, Leanne
Lyons, Hannah, Felton
Roper, Kristin
Spicer, Beverly, A.
Stocker, Doris, Layon

Trial Description

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.

Eligibility Requirements

Inclusion Criteria:

1. Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3

2. Has been treated with mastectomy

3. Has undergone immediate reconstructive surgery with placement of a tissue expander or
permanent implant at time of mastectomy

4. 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 required

6. Age ≥18

Exclusion Criteria:

1. T4 cancer

2. Recurrent breast cancer or history of prior breast radiation therapy

3. 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 study

4. Pregnant or nursing

5. History of a different malignancy except for the following circumstances:

- 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 skin

6. Breast cancer requiring bilateral breast/chest wall radiation therapy.