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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03422003
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : March 29, 2019
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Rinaa Punglia, MD MPH, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
Patient reported outcomes using the FACT-B [ Time Frame: 6 months ]
The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being sub-domain of the FACT-B.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03422003 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • Oncologic and clinical outcomes assessed using medical record abstractions. [ Time Frame: 10 years ]
    Clinical and oncologic outcomes (rare radiation side effects, recurrence, infections, additional surgeries) will be assessed over a period of 10 years through annual medical record abstractions.
  • Cosmetic outcomes assessed using photographic evaluations. [ Time Frame: 18 months ]
    Cosmetic outcomes (quality of reconstructive surgery throughout and after radiation therapy) will be assessed from baseline to 18 months by trained physicians using a standardized rating scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
Official Title  ICMJE Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
Brief Summary 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.
Detailed Description

Over 180,000 diagnoses of invasive breast cancer are made in the US each year. Over one‐third of women with early stage and over half with late‐stage breast cancer are treated with mastectomy (removal of the entire breast) due to tumor size, multiple cancers within the breast, genetic cancer predisposition, and/or patient preference. Following treatment with mastectomy, women who receive breast reconstructive surgery may experience better quality of life as they do not have to leave surgery with a bare chest wall. However, large randomized trials of post-mastectomy radiation therapy reveal a survival benefit with the addition of radiation after mastectomy in women who have cancer present in the axillary lymph nodes (6). The delivery of radiation therapy in the presence of a breast reconstruction is challenging and often leads to undesirable consequences including reconstruction loss, need for major surgical revision, or poor cosmetic outcomes. Therefore, oncologists and patients are forced to decide between the potential for improved oncologic outcomes with radiation therapy versus increased likelihood of complications and suboptimal cosmetic results. Because of this, some patients may be foregoing reconstruction if radiation therapy after mastectomy is needed; or foregoing radiation therapy if they have had breast reconstructive surgery (28).

Hypofractionation enhances patient convenience and decreases treatment burden. This regimen has been shown in randomized trials largely in the breast‐conservation setting to reduce acute radiation therapy side‐effects, decrease fatigue at six months and improve cosmetic results (21, 22). Despite these results, adoption of hypofractionation has been slow among women with breast cancer treated with breast‐conserving surgery (24, 25) likely due to familiarity and experience of conventional long‐course radiation therapy.

While hypofractionation is used commonly in the UK for patients with mastectomy, there are no randomized studies particularly studying outcomes following shorter course radiation therapy in women who undergo mastectomy with breast reconstruction. Therefore, there is an even greater barrier to the use of hypofractionation in this setting in the US. With improved cosmetic results found with hypofractionation, this shorter regimen may have the potential to improve reconstruction success rates which are unfortunately modest overall, for patients who require post-mastectomy radiation. Especially in contrast to financial disincentives to reduce number of radiation treatments, Level I randomized evidence is needed in this population to change practice patterns regarding radiation regimen.

Our study of radiation fractionation regimens has the potential to increase use of hypofractionation among women treated with mastectomy, thereby decreasing treatment burden. Our team of patient stakeholders ensures that our outcomes measures encompass all domains of survivorship after breast cancer (physical and mental health as well as satisfaction with the decision‐making process). Despite the large numbers of breast cancer survivors who undergo mastectomy, reconstruction and radiation therapy, little is known about which domains of quality of life are affected and their importance to these patients. This study uses previously validated tools for measuring patient outcomes, and have added questions for areas which are important to patients that may not have been captured adequately by previous tools. In concert with the increasing awareness of the importance of survivorship care to cancer care, identifying a comprehensive set of outcomes measurement tools following treatment with radiation therapy, mastectomy, and reconstruction is an important asset for future treatment evaluation in these women.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE Radiation: Radiation Therapy

For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600‐5000 cGy to the lymph nodes.

For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.

Study Arms  ICMJE
  • Experimental: Arm 1: Hypofractionation
    16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
    Intervention: Radiation: Radiation Therapy
  • Active Comparator: Arm 2: Conventional Radiation Therapy
    25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23‐25 fractions to the supraclavicular (with or without axillary) lymph nodes.
    Intervention: Radiation: Radiation Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2030
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosed with clinical or pathologic stage I‐III invasive breast cancer with TX‐T3 tumor
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rinaa Punglia, MD MPH 617-632-3591
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03422003
Other Study ID Numbers  ICMJE 16-304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rinaa Punglia, MD MPH, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Study Chair: Rinaa Punglia, MD MPH Dana-Farber Cancer Institute
Study Chair: Julia Wong, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP