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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:April 1, 2018
End Date:April 1, 2030
Contact:Rinaa Punglia, MD MPH
Email:rpunglia@partners.org
Phone:617-632-3591

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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.

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.

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.
We found this trial at
16
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Alice Ho, MD
Phone: 617-726-8651
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Abram Recht, MD
Phone: 617-667-2345
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Janice Kim, MD
Phone: 855-557-0555
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Rinaa Punglia, MD MPH
Phone: 617-632-3591
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brewer, Maine 04412
Principal Investigator: Kurt Snyder, MD
Phone: 207-973-4280
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Danvers, Massachusetts 01923
Principal Investigator: Daniel Soto, MD, MS
Phone: 978-882-6060
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Edwards, Colorado 81632
Principal Investigator: Patricia Hardenbergh, MD
Phone: 970-569-7429
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295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
Principal Investigator: Mathew Katz, MD
Phone: 978-937-6600
Lowell General Hospital Welcome to Lowell General Hospital! Our goal is to provide you with...
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20 Prospect Street
Milford, Massachusetts 01757
Principal Investigator: Ron Shiloh, MD
Phone: 781-624-4700
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Meena Moran, MD
Phone: 860-444-3744
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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167 Point Street
Providence, Rhode Island 02904
Principal Investigator: Kara Leonard, MD
Phone: 401-444-8311
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San Francisco, California 94143
Principal Investigator: Catherine Park, MD
Phone: 415-353-7175
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Scarborough, Maine 04074
Principal Investigator: Matthew Cheney, MD
Phone: 207-396-7500
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South Weymouth, Massachusetts
Principal Investigator: Laura Warren, MD
Phone: 781-624-4700
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Principal Investigator: Kathleen Horst, MD
Phone: 650-725-6009
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Washington, District of Columbia 20016
Principal Investigator: Jean Wright, MD
Phone: 202-537-4787
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