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

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03422003

Run by

Dana-Farber Cancer Institute

People needed

400

Starts

2018-04-01

Expected to finish

2030-04-01

Last updated by the study team

2024-11-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor
• Has been treated with mastectomy
• Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy
• 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)
• Use of bolus is permitted, but not required
• Age ≥18

You may not qualify if…

• T4 cancer
• Recurrent breast cancer or history of prior breast radiation therapy
• 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
• Pregnant or nursing
• 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
• Breast cancer requiring bilateral breast/chest wall radiation therapy.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Vail Health — Edwards, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Johns Hopkins Medicine — Washington D.C., District of Columbia, United States
• Eastern Maine Medical Center — Brewer, Maine, United States
• Maine Medical Center — Scarborough, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital/North Shore Center for Outpatient Care — Danvers, Massachusetts, United States
• Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center — Milford, Massachusetts, United States
• Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital — South Weymouth, Massachusetts, United States
• Lifespan/Rhode Island Hospital — Providence, Rhode Island, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.