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

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ClinicalTrials.gov Identifier: NCT03422003
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Rinaa Punglia, MD MPH, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiation Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : April 1, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.


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.
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422003


Contacts
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Contact: Rinaa Punglia, MD MPH 617-632-3591 rpunglia@partners.org

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Catherine Park, MD    415-353-7175      
Principal Investigator: Catherine Park, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Kathleen Horst, MD    650-725-6009      
Principal Investigator: Kathleen Horst, MD         
United States, Colorado
Vail Health Recruiting
Edwards, Colorado, United States, 81632
Contact: Patricia Hardenbergh, MD    970-569-7429      
Principal Investigator: Patricia Hardenbergh, MD         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Meena Moran, MD    860-444-3744      
Principal Investigator: Meena Moran, MD         
United States, District of Columbia
Johns Hopkins Medicine Recruiting
Washington, District of Columbia, United States, 20016
Contact: Jean Wright    202-537-4787      
Principal Investigator: Jean Wright, MD         
United States, Maine
Eastern Maine Medical Center Recruiting
Brewer, Maine, United States, 04412
Contact: Kurt Snyder, MD    207-973-4280      
Principal Investigator: Kurt Snyder, MD         
Maine Medical Center Recruiting
Scarborough, Maine, United States, 04074
Contact: Matthew Cheney, MD    207-396-7500      
Principal Investigator: Matthew Cheney, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alice Ho, MD    617-726-8651      
Principal Investigator: Alice Ho, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Abram Recht, MD    617-667-2345      
Principal Investigator: Abram Recht, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Rinaa Punglia, MD MPH    617-632-3591      
Principal Investigator: Rinaa Punglia, MD MPH         
Principal Investigator: Julia Wong, MD         
Massachusetts General Hospital/North Shore Center for Outpatient Care Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Daniel Soto, MD, MS    978-882-6060      
Principal Investigator: Daniel Soto, MD, MS         
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01852
Contact: Mathew Katz, MD    978-937-6600      
Principal Investigator: Mathew Katz, MD         
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center Recruiting
Milford, Massachusetts, United States, 01757
Contact: Ron Shiloh, MD    781-624-4700      
Principal Investigator: Ron Shiloh, MD         
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital Recruiting
South Weymouth, Massachusetts, United States, 02190
Contact: Laura Warren, MD    781-624-4700      
Principal Investigator: Laura Warren, MD         
United States, Rhode Island
Lifespan/Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kara Leonard, MD    401-444-8311      
Principal Investigator: Kara Leonard, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Janice Kim, MD    855-557-0555      
Principal Investigator: Janice Kim, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Patient-Centered Outcomes Research Institute
Investigators
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Study Chair: Rinaa Punglia, MD MPH Dana-Farber Cancer Institute
Study Chair: Julia Wong, MD Dana-Farber Cancer Institute

Publications:

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Responsible Party: Rinaa Punglia, MD MPH, Prinicipal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03422003     History of Changes
Other Study ID Numbers: 16-304
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Rinaa Punglia, MD MPH, Dana-Farber Cancer Institute:
Breast Cancer
Radiation
Hypofractionation
Randomization

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases