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Study of radiation Fractionation on outcomes After Breast REConstruction (FABREC)
Investigator (PI): Punglia, Rinaa Sujata
Performing Organization (PO): (Current): Dana-Farber Cancer Institute, Department of Radiation Oncology / (617) 632-3591
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2023
Record Source/Award ID: PCORI/CER-1609-36063 ; PCORI/APDTO-1609-36063
Funding: Total Award Amount: $2,640,773
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Almost 100,000 women receive mastectomy (removal of the breast) to treat breast cancer each year in the United States. Many of these women prefer to undergo breast reconstruction at the same time as mastectomy, rather than having a flat chest wall after surgery. Women who are found to have cancer in their lymph nodes at mastectomy are usually recommended to undergo radiation therapy to decrease the chance of cancer recurrence and improve survival. Radiation therapy requires at least five weeks of daily visits and almost half of the time can lead to poor outcomes, including scarring and pain around the reconstruction, need for revision surgery, and compromised cosmetic results. Because of these problems, some women who might benefit from radiation do not receive it. Hypofractionation, an innovative three-week, short course radiation regimen, may allow women to get the radiation they need to help prevent recurrence while minimizing the effect on reconstruction outcomes and improving their overall experience with breast cancer care. The effectiveness of short course radiation has been confirmed by randomized trials of radiation after breast conserving surgery, revealing improved quality of life and cosmetic results, and equivalent or better cancer control. In contrast, there are no rigorous studies specifically assessing outcomes following short course radiation therapy in women who undergo mastectomy with reconstruction. The Study of Fractionation on Outcomes After Breast REConstruction (FABREC) is a randomized clinical trial of short course (three-week) versus long course (five-week--"conventional") radiation therapy in 232 women with mastectomy and reconstruction for invasive breast cancer. After the need for radiation is established, patients will be randomized to receive one of these two treatment regimens. They will fill out surveys assessing patient reported outcomes, and will also be evaluated for surgical complications, cosmetic outcomes, and cancer status. The study's primary outcome, physical well-being, has been identified as highly relevant by patients who have received radiation after reconstruction in the team's preliminary study. These patients have expressed a strong willingness to enroll in a trial randomizing patients to short course versus long course treatment. Breast cancer patients, patient advocates, and other stakeholders have helped guide the trial design and selected the survey questions and outcomes. Patients will continue to be meaningfully involved in all subsequent study processes. FABREC will be conducted at academic and community practice sites to ensure a diverse and representative patient population. The results will provide critical evidence regarding the optimal radiation regimen for women with breast cancer who opt for mastectomy and reconstruction, and has the potential to change practice so that women in this clinical scenario receive truly patient centered care.
MeSH Terms:
  • Breast Neoplasms /*radiotherapy
  • /*surgery
  • Dose Fractionation, Radiation
  • Female
  • Humans
  • Lymphatic Metastasis /radiotherapy
  • Mammaplasty
  • Mastectomy
  • Neoplasm Recurrence, Local /prevention & control
  • Outcome Assessment, Health Care
  • Patient-Centered Care
  • Program Development
  • Program Evaluation
  • Quality of Life
  • Radiotherapy
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
Country: United States
State: Massachusetts
Zip Code: 02215
UI: 20181378
Project Status: Ongoing
Record History: ('2018: Start date changed from 2017 to 2018 and project extended to 2023.',)