Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Each year in the United States, about 100,000 women with breast cancer have surgery to remove a breast, called mastectomy. Many of these women choose to have breast reconstruction at the same time as mastectomy. Breast reconstruction is surgery to rebuild the breast using a breast implant or the woman’s own tissue.

Doctors may suggest radiation therapy if they find cancer in a woman’s lymph nodes during surgery. This therapy lowers the chance that the cancer will come back, but it requires five weeks of daily clinic visits. In addition, nearly half of women have side effects that damage the rebuilt breast. These side effects include scarring, pain, or the need for more surgery to repair the new breast.

In this study, the research team is comparing two ways to provide radiation to women who had a mastectomy with breast reconstruction:

  • Standard therapy. Women receive the standard number of treatments over five weeks at the usual dose.
  • Short-course therapy. Women receive fewer treatments over three weeks at a slightly higher dose compared with standard therapy.

The research team wants to compare how the different approaches affect women’s physical well-being.

Who can this research help?

Women with breast cancer who get mastectomy with breast reconstruction and their doctors can use results from this study when considering radiation therapy options.

What is the research team doing?

The research team is recruiting 400 women ages 18 and older with breast cancer who had a mastectomy followed by immediate reconstruction. The women are patients in academic and community medical centers across the United States. When a doctor finds that a woman needs radiation, the research team assigns that patient by chance to get standard or short-course therapy. The team is surveying patients prior to radiation and six months later to assess their physical well-being. Then, 18 months after surgery, the team is measuring the quality of breast reconstruction using a standard rating scale. Finally, 10 years after surgery, the team is looking at medical records to see if the cancer came back and whether patients had side effects from radiation, infections, or more surgeries. The team is comparing results between the two groups.  

Breast cancer survivors, patient advocates, and health system administrators are helping with the study. They are providing input into research questions and outcomes, trial design, and survey questions.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 400 women ages 18 and older diagnosed with clinical or pathologic stage I–III invasive breast cancer who have undergone mastectomy and immediate breast reconstruction
Interventions/
Comparators
  • Standard (5-week) radiation therapy
  • Short-course (3-week) radiation therapy (hypofractionation)
Outcomes

Primary: physical well-being

Secondary: rare radiation side effects, breast cancer recurrence, infections, additional surgeries, quality of reconstructive surgery throughout and after radiation therapy

Timeframe 6-month follow-up for primary outcome

Project Information

Rinaa Sujata Punglia, MD
Dana-Farber Cancer Institute
$2,640,774
Study of Radiation Fractionation on Outcomes After Breast REConstruction (FABREC)

Key Dates

August 2017
September 2024
2017

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: January 24, 2024